Results:
During weeks 1-24, 9.1% (9/99) of m-DOT participants reported missing doses compared with 19.1% (20/105) of controls (P = 0.04) and 96.5% (517/571) of m-DOT pill-count measures were >or=95% compared with 86.1% (445/517) in controls [adjusted odds ratio = 4.4; 95% confidence interval (CI) = 2.6 to 7.5; P < 0.001. Adherence with m-DOT was 4.8 times greater (95% CI = 2.7 to 8.6; P < 0.001) with adjustment for depression and HIV-related hospitalization. In weeks 25-48, adherence with m-DOT (488/589) was similar to controls (507/630). Viral suppression at 48 weeks was 2.0 times (95% CI = 0.8 to 5.2; P = 0.13) as likely in m-DOT participants as controls. M-DOT patients had larger body mass index increases at 24 weeks (2.2 vs 1.4 kg/m3; P = 0.014). Viral suppression was more likely at week 48 (21/25 vs 13/22; P = 0.057) and week 72 (27/30 vs 15/23; P = 0.027) among depressed participants receiving m-DOT.
Conclusions:
M-DOT increased adherence, most notably among depressed participants.
Promoting adherence to antiretroviral therapy through a directly administered antiretroviral therapy (DAART) strategy in Mombasa, Kenya.
Author: Sarna A; Luchters S; Geibel S; Munyao P, and Kaai, S.
Abstract: A principal concern of antiretroviral therapy (ART) programs is the ability of patients to maintain a high level of adherence to the medication regimen. Based on formative research conducted on HIV-infected clients and health workers in Mombasa, Kenya, and lessons learned from directly observed therapy (DOT) strategies to encourage adherence to treatment for tuberculosis, a DAART strategy was developed to promote adherence to ART. This study examines whether the DAART intervention is more effective in fostering adherence than standard follow-up strategies among people living with HIV/AIDS in Mombasa. (excerpt)
Does being treated with HAART affect the sexual risk behavior of people living with HIV / AIDS? Insights from Mombasa, Kenya.
Author: Sarna A; Luchters S; Kaai S; Munyao P, and Geibel, S.
Abstract: To learn more about the impact of HAART on sexual risk behavior in a developing country setting, researchers from the Horizons Program, the International Center for Reproductive Health, and implementation partners at Coast Province General Hospital, Mkomani Bomu Clinic, and Port Reitz District Hospital, embarked on a prospective intervention study in Mombasa, Kenya. One objective of the study was to compare the sexual risk behaviors of HIV infected persons receiving HAART to those of HIV-infected persons who were not clinically eligible to be candidates for HAART, but were receiving prophylaxis or preventive therapy. (excerpt)
Sexual risk behaviour and HAART: a comparative study of HIV-infected persons on HAART and on preventive therapy in Kenya.
Author: Sarna, A.; Luchters, S. M.; Geibel, S.; Kaai, S.; Munyao, P.; Shikely, K. S.; Mandaliya, K.; van Dam, J., and Temmerman, M.
Source: Int J STD AIDS. 2008 Feb; 19(2):85-9.
Abstract: Unprotected sex (UPS) among persons receiving highly active antiretroviral therapy (HAART) remains a concern because of the risk of HIV-transmission. A cross-sectional study comparing the sexual risk behaviour of 179 people living with HIV/AIDS (PLHA) receiving HAART with that of 143 PLHA receiving preventive therapy (PT) with cotrimoxazole/isoniazid was conducted in Mombasa, Kenya. Forty-five percent of all participants were sexually active in the last six months. Participants receiving PT were more likely to report > or =2 partners (13% vs.1%; P = 0.006). Participants receiving PT reported more UPS with regular partners (odds ratio [OR]: 3.9; 95% confidence interval [CI]: 1.8-8.4) and also more sexually transmitted infections (STI) symptoms (OR: 1.7; 95% CI: 1.0-2.8; P = 0.059). More than 40% of all participants did not know the HIV-status of regular partners. Therefore, HAART was not associated with increased sexual risk behaviours though considerable risk of HIV-transmission remains. HIV-care services need to emphasize partner testing and consistent condom use with all partners.
Male circumcision and HIV/AIDS: challenges and opportunities.
Author: Sawires, S. R.; . = Dworkin SL; Fiamma A; Peacock D, and Szekeres G.
Source: Lancet. 2007 Feb 24; 369(9562):708-713.
Abstract: On December 13, 2006, the National Institutes of Health (NIH) announced the early termination of two randomised controlled trials of male circumcision - in Kenya and Uganda - on the basis of interim evidence that male circumcision provided a protective benefit against HIV infection of 53% among the 2784 Kenyan men and 51% among the 4996 Ugandan men enrolled in the respective studies. The Kenya and Uganda trials replicated the landmark findings of the South African Orange Farm study, the first randomised controlled trial to report a greater than 50% protective benefit of male circumcision. Before the availability of data from these three African randomised controlled trials, multiple observational studies correlated male circumcision with reduced risk of HIV infection. Systematic reviews and meta-analysis of observational studies provide further evidence of the association of male circumcision with reduced risk of HIV infection and a plausible explanation for the biological mechanism for reduced risk of infection has been suggested. Recently released longitudinal evidence of the range of health benefits that male circumcision provides, modelling based on the South African trials, and cost-effectiveness data in both North America and Africa provide further evidence to support the health benefits of male circumcision. Male circumcision is also associated with reduced risk of urinary tract infections, genital ulcer diseases, penile cancer, and a possible reduction in transmission of human papillomavirus (HPV) exists. Yet enthusiasm generated from the three trials might not lead to accelerated scale-up. Regrettably, the global experience with access to antiretroviral drugs shows that strong science alone does not result in rapid, widespread roll-out. Not until civil society, non-governmental organisations, and a chorus of advocacy groups successfully lobbied for universal access to antiretrovirals did widespread roll-out in areas with a high burden of HIV areas begin in earnest. Rapid implementation of male circumcision will probably require a similar effort. (excerpt)
Characterization of intersubtype recombinant HIV type 1 genomes using a nonradioactive heteroduplex tracking assay.
Author: Schroeder, T. L.; Burger, H.; Weiser, B.; Bengualid, V.; Kimani, J.; Anzala, A. O.; Parker, M. M.; Lamson, D., and Philpott, S. M.
Source: AIDS Res Hum Retroviruses. 2005 Apr; 21(4):314-8.
Abstract: The HIV-1 epidemic is characterized by the dominance of distinct viral subtypes in different regions of the world, and intersubtype recombinants are common. Traditional subtyping methods analyze only a small fragment of the HIV-1 genome, so the true extent of diversity and recombination has been difficult to examine. We developed a heteroduplex tracking assay (HTA) to identify viral subtypes and rapidly detect recombinant HIV-1 genomes. By using probes that target seven regions across the HIV-1 genome, HTAs can identify intersubtype recombinants on the basis of the heteroduplex mobility pattern. We used this method to analyze HIV-1 strains from 12 patients from the United States and Kenya, comparing the results with those obtained by sequencing. HTA analysis correctly identified the subtype of each region of the genome, revealing that several isolates were recombinants. This method is suitable for studies of HIV-1 diversity and recombination in areas of the world where multiple subtypes are found.
Anal and dry sex in commercial sex work, and relation to risk for sexually transmitted infections and HIV in Meru, Kenya.
Author: Schwandt, M.; Morris, C.; Ferguson, A.; Ngugi, E., and Moses, S.
Source: Sex Transm Infect. 2006 Oct; 82(5):392-6.
Abstract: Objective:
To examine the practices of anal intercourse and dry sex within a cohort of female sex workers (FSWs) in Kenya, focusing on the prevalence and perceived risk of the practices, demographic and behavioural correlates, and association with sexually transmitted infections (STI).
Methods:
A survey was conducted among FSWs in Meru, Kenya, with 147 participants randomly sampled from an existing cohort of self identified FSWs.
Results:
40.8% of participants reported ever practising anal intercourse and 36.1% reported ever practising dry sex. Although the majority of women surveyed believed anal intercourse and dry sex to be high risk practices for HIV infection compared with vaginal sex, about one third of women reported never or rarely using condoms during anal intercourse, and about 20% never or rarely using condoms during dry sex. Reported consistent condom use was lower with both of these practices than with penile-vaginal intercourse. Anal intercourse was associated with experience of recent forced sexual intercourse, while dry sex was not. Anal intercourse was almost always initiated by clients, whereas dry sex was likely to be initiated by the women themselves. Sex workers reported charging higher fees for both practices than for vaginal intercourse. Both practices were associated with reported symptoms and diagnoses of STI.
Conclusions:
Both anal intercourse and dry sex were common in this sample, and although perceived as high risk practices, were not adequately protected with condom use. Education and other interventions regarding these high risk sexual behaviours need to be translated into safer practices, particularly consistent condom use, even in the face of financial vulnerability.
Can data from programs for the prevention of mother-to-child transmission of HIV be used for HIV surveillance in Kenya?
Author: Seguy, N.; Hladik, W.; Munyisia, E.; Bolu, O.; Marum, L. H., and Diaz, T.
Can data from programs for the prevention of mother-to-child transmission of HIV be used for HIV surveillance in Kenya?
Source: Public Health Rep. 2006 Nov-2006 Dec 31; 121(6):695-702.
Abstract: Objective:
In Africa, HIV surveillance is conducted among antenatal clinic (ANC) attendees using unlinked-anonymous testing (UAT). In Kenya, the utility of prevention of mother-to-child transmission (PMTCT) program data for HIV surveillance was evaluated.
Methods:
UAT and PMTCT data were compared at the same clinics and for the same time (2003 UAT survey) period. The HIV testing uptake for PMTCT was defined as the number of ANC attendees tested for HIV out of those who had their first ANC visit during the ANC surveillance period. Odds ratios and 95% confidence intervals were calculated to determine associations between demographic characteristics and HIV testing acceptance.
Results:
Of 39 ANC-UAT sites, six had PMTCT data. PMTCT data were recorded across several logbooks with varying quality. For PMTCT, 2,239 women were offered HIV testing and 1,258 (56%) accepted; for UAT, 1,852 women were sampled. Median UAT-based HIV prevalence was 12.8% (range, 8.1%-26.3%) compared with 14.4% (range, 7.0%-27.2%) in PMTCT. HIV testing acceptance for PMTCT ranged from 48% to 69% across clinics, and was more likely among primigravidae than multigravidae.
Conclusion:
Because of varying PMTCT data quality and varying HIV testing acceptance for PMTCT, PMTCT-based HIV prevalence estimates cannot currently replace UAT-based estimates in Kenya.
Report and policy brief from the 4th Africa Conference on Social Aspects of HIV/AIDS Research: innovations in access to prevention, treatment and care in HIV/AIDS, Kisumu, Kenya, 29 April - 3 May 2007.
Author: Setswe, G.; Peltzer, K.; Banyini, M.; Skinner, D.; Seager, J.; Maile, S.; Sedumedi, S.; Gomis, D., and van der Linde, I.
Source: SAHARA J. 2007 Aug; 4(2):640-51.
Abstract: About 520 delegates from all over Africa and 21 countries attended the conference.This report and policy brief summarises the key findings and suggested policy options that emerged from rapporteur reports of conference proceedings including the following themes: (1) Orphans and vulnerable children, (2) Treatment, (3) Prevention, (4) Gender and male involvement, (5) Male circumcision, (6) People living with HIV/AIDS, (7) Food and nutrition, (8) Socioeconomics, and (9) Politics/policy. Two (11.8%) of the 17 OVC projects from the three countries were classified as best practice interventions. Of the 83 abstracts that were accepted at the conference, only 7 (8.4%) were dealing with antiretroviral therapy (ART). There has been tremendous effort by various organisations to provide information about prevention of HIV/AIDS. Information received by adolescents has been effective in increasing their knowledge, but without positive sexual behaviour change. The conference noted the contribution of gender discrimination and violence to the HIV epidemic and the different risks that men and women face in relation to the epidemic. Social scientists need to study the deep cultural meanings attached to male circumcision among different ethnic groups to be able to guide the debate on the latest biomedical findings on the protective effect of circumcision against HIV. Palliative care and support is crucial for coping among people living with HIV/AIDS (PLWHA) in order to deal with medical and psychological issues. Results from several countries have helped researchers to explore alternative ways of examining poverty in the context of HIV and AIDS. Policy frameworks which are likely to succeed in combating HIV/AIDS need to be updated to cover issues of access, testing, disclosure and stigma. In general, the conference was successful in identifying innovations in access to prevention, treatment and care in HIV/AIDS.
Characteristics of psychosocial support seeking during HIV-related treatment in western Kenya.
Author: Shacham, E.; Reece, M.; Ong'or, W. O.; Omollo, O.; Monahan, P. O., and Ojwang, C.
Source: AIDS Patient Care STDS. 2008 Jul; 22(7):595-601.
Abstract: While the characteristics of those who seek psychosocial support following an HIV diagnosis have been well documented in western countries where linkages between HIV-related treatment and psychosocial support programs are well established, little is known about those who become engaged with such services in countries of the world where comprehensive HIV-related care and prevention systems are continuing to develop. Data were collected from 397 individuals who had enrolled in HIV-related psychosocial support groups in western Kenya in November 2005. Demographic and HIV-related characteristics, as well as assessments of psychological distress, were collected from each participant and analyzed by gender in order to document the characteristics of those seeking psychosocial care in conjunction with their participation in an HIV-related treatment and prevention program. Those seeking psychosocial support were primarily female (72%), living with HIV for an average of 2.5 years, and unemployed (70%). Women were younger and more likely to be either widowed or never married; while men were more likely to have advanced HIV disease, including lower CD4 counts and an AIDS diagnosis. Across all participants, HIV serostatus disclosure was rarely reported to sex partners, family members, and friends. Symptoms of psychological distress were more prevalent among women on multiple measures, including depression, anxiety, paranoid ideation, interpersonal sensitivity, and somatization. An increased understanding of the characteristics of those likely to seek psychosocial support groups will help HIV program managers to develop protocols necessary for facilitating linkages to psychosocial support for those enrolled in HIV-related treatment programs. Patient engagement in psychosocial support may facilitate improvements in psychological function and support an individual's maintenance of HIV treatment and prevention behaviors.
The protective effect of circumcision on HIV incidence in rural low-risk men circumcised predominantly by traditional circumcisers in Kenya: two-year follow-up of the Kericho HIV Cohort Study.
Author: Shaffer, D. N.; Bautista, C. T.; Sateren, W. B.; Sawe, F. K.; Kiplangat, S. C.; Miruka, A. O.; Renzullo, P. O.; Scott, P. T.; Robb, M. L.; Michael, N. L., and Birx, D. L.
Source: J Acquir Immune Defic Syndr. 2007 Aug 1; 45(4):371-9.
Abstract: Background:
Three randomized controlled trials (RCTs) have demonstrated that male circumcision prevents female-to-male HIV transmission in sub-Saharan Africa. Data from prospective cohort studies are helpful in considering generalizability of RCT results to populations with unique epidemiologic/cultural characteristics.
Methods:
Prospective observational cohort sub-analysis. A total of 1378 men were evaluated after 2 years of follow-up. Baseline sociodemographic and behavioral/HIV risk characteristics were compared between 270 uncircumcised and 1108 circumcised men. HIV incidence rates (per 100 person-years) were calculated, and Cox proportional hazards regression analyses estimated hazard rate ratios (HRs).
Results:
Of the men included in this study, 80.4% were circumcised; 73.9% were circumcised by traditional circumcisers. Circumcision was associated with tribal affiliation, high school education, fewer marriages, and smaller age difference between spouses (P < 0.05). After 2 years of follow-up, there were 30 HIV incident cases (17 in circumcised and 13 in uncircumcised men). Two-year HIV incidence rates were 0.79 (95% confidence interval [CI]: 0.46 to 1.25) for circumcised men and 2.48 (95% CI: 1.33 to 4.21) for uncircumcised men corresponding to a HR = 0.31 (95% CI: 0.15 to 0.64). In one model controlling for sociodemographic factors, the HR increased and became non-significant (HR = 0.55; 95% CI: 0.20 to 1.49).
Conclusions:
Circumcision by traditional circumcisers offers protection from HIV infection in adult men in rural Kenya. Data from well-designed prospective cohort studies in populations with unique cultural characteristics can supplement RCT data in recommending public health policy.
Equitable treatment for HIV/AIDS clinical trial participants: a focus group study of patients, clinician researchers, and administrators in Western Kenya.
Author: Shaffer, D. N.; Yebei, V. N.; Ballidawa, J. B.; Sidle, J. E.; Greene, J. Y.; Meslin, E. M.; Kimaiyo, S. J., and Tierney, W. M.
Source: J Med Ethics. 2006 Jan; 32(1):55-60.
Abstract: Objectives:
To describe the concerns and priorities of key stakeholders in a developing country regarding ethical obligations held by researchers and perceptions of equity or "what is fair" for study participants in an HIV/AIDS clinical drug trial.
Design: Qualitative study with focus groups.
Setting:
Teaching and referral hospital and rural health centre in Western Kenya. PARTICIPANTS: Potential HIV/AIDS clinical trial participants, clinician researchers, and administrators.
Results:
Eighty nine individuals participated in a total of 11 focus groups over a four month period. The desire for continued drug therapy, most often life long, following an HIV/AIDS clinical trial was the most common priority expressed in all focus groups. Patients with and without HIV/AIDS also thought subsidizing of drug therapies and education were critical forms of compensation for clinical trial participation. Financial incentives were considered important primarily for purchasing drug therapy as well as obtaining food. Patients noted a concern for the potential mismanagement of any money offered. Clinician researchers and administrators felt strongly that researchers have a moral obligation to participants following a trial to provide continued drug therapy, adverse event monitoring, and primary care. Finally, clinician researchers and administrators stressed the need for thorough informed consent to avoid coercion of study participants.
Conclusions:
Kenyan patients, clinician researchers, and administrators believe that it would be unfair to stop antiretroviral therapy following an HIV/AIDS clinical trial and that researchers have a long term obligation to participants.
HIV immunosuppression and antimalarial efficacy: sulfadoxine-pyrimethamine for the treatment of uncomplicated malaria in HIV-infected adults in Siaya, Kenya.
Author: Shah, S. N.; Smith, E. E.; Obonyo, C. O.; Kain, K. C.; Bloland, P. B.; Slutsker, L., and Hamel, M. J.
Source: J Infect Dis. 2006 Dec 1; 194(11):1519-28.
Abstract: Background:
The altered immune response of persons with human immunodeficiency virus (HIV) infection could result in increased rates of antimalarial treatment failure. We investigated the influence of HIV infection on the response to sulfadoxine-pyrimethamine treatment.
Methods:
Febrile adults with Plasmodium falciparum parasitemia were treated with sulfadoxine-pyrimethamine and were monitored for 28 days. HIV status and CD4 cell count were determined at study enrollment.
Results:
Of the adults enrolled in the study, 508 attended all follow-up visits, including 130 HIV-uninfected adults, 256 HIV-infected adults with a high CD4 cell count (> or =200 cells/ micro L), and 122 HIV-infected adults with a low CD4 cell count (<200 cells/ micro L). The hazard of treatment failure at day 28 of follow-up was significantly higher for HIV-infected adults with a low CD4 cell count (20.5%) than for HIV-uninfected adults (7.7%). Anemia (hemoglobin level, <110 g/L) modified the effect of HIV status on treatment failure. When we controlled for fever and parasite density, the hazard of treatment failure for HIV-infected adults with a low CD4 cell count and anemia was 3.4 times higher than that for HIV-uninfected adults (adjusted hazard ratio, 3.38; 95% confidence interval, 1.56-7.34).
Conclusions:
HIV-infected persons with a low CD4 cell count and anemia have an increased risk of antimalarial treatment failure. The response to malaria treatment in HIV-infected persons must be carefully monitored. Proven measures for the control and prevention of malaria must be incorporated into the basic package of services provided by HIV/acquired immunodeficiency syndrome care and treatment programs in malarious areas.
Mucosal Neisseria gonorrhoeae coinfection during HIV acquisition is associated with enhanced systemic HIV-specific CD8 T-cell responses.
Author: Sheung, A.; Rebbapragada, A.; Shin, L. Y.; Dobson-Belaire, W.; Kimani, J.; Ngugi, E.; MacDonald, K. S.; Bwayo, J. J.; Moses, S.; Gray-Owen, S., and Kaul, R.
Source: AIDS. 2008 Sep 12; 22(14):1729-37.
Abstract: Background:
The host immune response against mucosally acquired pathogens may be influenced by the mucosal immune milieu during acquisition. As Neisseria gonorrhoeae can impair dendritic cell and T-cell immune function, we hypothesized that coinfection during HIV acquisition would impair subsequent systemic T-cell responses.
Methods:
Monthly screening for sexually transmitted infections was performed in high risk, HIV seronegative Kenyan female sex workers as part of an HIV prevention trial. Early HIV-specific CD8 T-cell responses and subsequent HIV viral load set point were assayed in participants acquiring HIV, and were correlated with the presence of prior genital infections during HIV acquisition.
Results:
Thirty-five participants acquired HIV during follow-up, and 16 out of 35 (46%) had a classical sexually transmitted infection at the time of acquisition. N. gonorrhoeae coinfection was present during HIV acquisition in 6 out of 35 (17%), and was associated with an increased breadth and magnitude of systemic HIV-specific CD8 T-cell responses, using both interferon-gamma gamma and MIP-1 beta as an output. No other genital infections were associated with differences in HIV-specific CD8 T-cell response, and neither N. gonorrhoeae nor other genital infections were associated with differences in HIV plasma viral load at set point.
Conclusion:
Unexpectedly, genital N. gonorrhoeae infection during heterosexual HIV acquisition was associated with substantially enhanced HIV-specific CD8 T-cell responses, although not with differences in HIV viral load set point. This may have implications for the development of mucosal HIV vaccines and adjuvants.
Bronchoscopic study on aetiology of chronic cough in HIV-infected adults with negative sputum smears for Mycobacterium tuberculosis at Kenyatta National Hospital, Nairobi.
Author: Siika, A. M.; Chakaya, J. M.; Revathi, G.; Mohamed, S. S., and Bhatt, K. M.
Source: East Afr Med J. 2006 Jun; 83(6):295-305.
Abstract: Objective:
To establish the aetiology of chronic cough in HIV-infected patients with negative sputum smears for Acid Fast Bacilli (AFB).
Design: A cross-sectional descriptive study.
Setting: Kenyatta National Hospital, a tertiary referral centre in Kenya
Subjects:
Sixty five HIV-infected adults presenting with chronic cough and negative sputum smears for AFBs.
Results:
Sixty-two patients were included in the final analysis. Aetiology of chronic cough was established in 42 (68%) patients. Pneumocystis jiroveci, bacterial pneumonia and Mycobacterium tuberculosis were diagnosed in 22 (35.5%), 17 (27.4%) and 14 (22.5%) patients respectively. Majority (98%) of patients with a diagnosis had multiple causes established in them. Ciprofloxacin had activity against 91% of the isolated organisms while Penicillin was active against 35% only.
Conclusion:
This study documents Pneumocystis jiroveci pneumonia as a common cause of morbidity in a subset of HIV infected patients with chronic cough and negative sputum smears for AFB in Kenya.
Modified vaccinia Ankara expressing HIVA antigen stimulates HIV-1-specific CD8 T cells in ELISpot assays of HIV-1 exposed infants.
Author: Slyker, J. A.; Lohman, B. L.; Mbori-Ngacha, D. A.; Reilly, M.; Wee, E. G.; Dong, T.; McMichael, A. J.; Rowland-Jones, S. L.; Hanke, T., and John-Stewart, G.
Source: Vaccine. 2005 Sep 7; 23(38):4711-9.
Abstract: Recombinant modified vaccinia virus Ankara expressing HIV-1 antigens (MVA.HIVA) was used in ELISpot assays to monitor HIV-1-specific T cell responses in infants. Responses to MVA.HIVA and HIV-1 peptides were examined in 13 infected and 81 exposed uninfected infants in Nairobi, Kenya. Responses to MVA.HIVA (38%) and peptide stimulation (38%) were similar in frequency (p=1.0) and magnitude (mean 176 versus 385 HIVSFU/10(6), p=0.96) in HIV-1 infected infants. In exposed uninfected infants, MVA.HIVA detected more positive responses and higher magnitude responses as compared to peptide. MVA.HIVA ELISpot is a sensitive method for quantification of HIV-1-specific CD8+ T cell responses in HIV-1 exposed infants. These results demonstrate the relevance of HIV-1 clade A consensus-derived immunogen HIVA for the viruses currently circulating in Nairobi.
Efficacy of highly active antiretroviral therapy in HIV-1 infected children in Kenya.
Author: Song, R.; Jelagat, J.; Dzombo, D.; Mwalimu, M.; Mandaliya, K.; Shikely, K., and Essajee, S.
Source: Pediatrics. 2007 Oct; 120(4):e856-61.
Abstract: Objective:
Few studies have investigated the efficacy of antiretroviral therapy among HIV-infected children in resource-poor settings. This observational, retrospective analysis describes the clinical, immunologic, and virologic effects of highly active antiretroviral therapy in treatment-naive, HIV-infected children in Mombasa, Kenya. In keeping with a public health approach, all children were treated by using a simplified, nationally approved, triple-drug regimen.
Methods:
Clinical data and stored plasma samples from 29 children who were followed prospectively between April 2003 and October 2004 were analyzed. All children received generic formulations of nevirapine, zidovudine, and lamivudine and were evaluated at baseline and at 3, 6, 9, 12, and 15 months. At each visit, weight and CD4 lymphocyte counts were measured and plasma samples were stored for analysis. HIV RNA load was determined retrospectively at baseline and 9 months after initiation of therapy.
Results:
The mean age of the children was 8.5 years (range: 2-16 years). At baseline, the mean CD4 count (+/-SD) was 182.3 x 10(6) cells per microL (+/-145.6). On treatment, CD4 counts increased step-wise by a mean of 187 x 10(6) cells per microL at 3 months, 293 cells per microL at 6 months, 308 cells per microL at 9 months, 334 cells per microL at 12 months, and 363 cells per microL at 15 months. The mean plasma viral load decreased from a baseline level of 622,712 to 35,369 copies per mL, and at 9 months was undetectable in 55% of the patients. Mean z scores for weight for age increased from a baseline of -1.61 to -1.12 at 12 months into therapy.
Conclusions:
A public health approach using 1 treatment regimen in generic form showed excellent efficacy among treatment-naive, HIV-infected children in a resource-limited country. Clinical and immunologic improvement occurred in all patients, but 9 months after the start of therapy, only 55% of the children had an undetectable viral load.
Implementation of an antiretroviral access program for HIV-1-infected individuals in resource-limited settings: clinical results from 4 African countries.
Author: Sow, P. S.; Otieno, L. F.; Bissagnene, E.; Kityo, C.; Bennink, R.; Clevenbergh, P.; Wit, F. W.; Waalberg, E.; Rinke de Wit, T. F., and Lange, J. M.
Source: J Acquir Immune Defic Syndr. 2007 Mar 1; 44(3):262-7.
Abstract: Background:
We assessed the effectiveness and safety of highly active antiretroviral therapy (HAART) in HIV-1-infected patients in resource-limited African countries. HIV-1 screening, therapy, counseling, monitoring, training, and education were provided free of charge.
Methods:
In an open-label cohort program, 206 antiretroviral-naive HIV-1-infected patients who could not afford HAART were recruited in 4 urban clinics in Senegal, Cote d'Ivoire, Uganda, and Kenya and were treated with saquinavir boosted with ritonavir (1600/100 mg once daily), lamivudine (150 mg twice daily), and zidovudine (300 mg twice daily). The primary outcome was a plasma viral load (pVL) of <400 copies/mL after 96 weeks of treatment. Secondary analyses included CD4 cell count changes and the occurrence of treatment-emergent adverse events.
Results:
The median age of the patient group was 36 years, 38% were male, 35% of the patients had AIDS, the median CD4 count was 119 cells/microL, and the median pVL was 304,210 copies/mL. Overall, 65%/52% (on treatment [OT]/intent to treat [ITT]) of the patients had a pVL <400 copies/mL after 96 weeks of follow-up. This proportion varied significantly between sites, however; although in Nairobi and Dakar, 51%/40% and 56%/46% (OT/ITT) were found, respectively, Abidjan and Kampala showed proportions of 69%/54% and 83%/69% (OT/ITT), respectively. The median increase in the CD4 count was 198 cells/microL (interquartile range: 86-319 cells/microL), ranging from 191 to 292 cells/microL between the sites. Fourteen patients (6.8%) died between 8 and 96 weeks of follow-up, whereas 18 (9%) developed an AIDS-defining event between 8 and 96 weeks of follow-up. Non-HIV-related serious adverse events occurred in 55 patients (26.7%), of whom 13 were diagnosed with severe anemia. Thirty-five patients (17%) changed treatment for toxicity reasons.
Conclusions:
Although a statistically significant difference was observed between sites with respect to virologic success, overall virologic and immunologic responses to HAART in resource-limited African settings can be as good as in Western settings. There were some difficulties (eg, laboratory, logistics, proper training) during the early phase of the program. Therefore, provision of adequate medical care, counseling, proper instruction, and education of patients and medical staff during the entire study is warranted in such programs, with special care in the early phase.
Analysis of HIV-1 sequences vertically transmitted to infants in Kisumu, Kenya.
Author: Steain, M. C.; Wang, B., and Saksena, N. K.
Source: J Clin Virol. 2006 Aug; 36(4):298-302.
Abstract: Background:
HIV-1 prevalence in Kenya among women aged between 15-19 years is approximately 23%. These women are prospective mothers and therefore can play an important role in mother-to-child transmission of HIV. The risk of a seropositve mother transmitting the virus to her infant is 25-35% in developing countries, such as Kenya, where antiretroviral drugs are not readily available.
Objectives:
This study was undertaken to evaluate the molecular nature of HIV-1 strains, assess recombination and it's relevance in mother-to-child transmission in Kenya.
Study design:
HIV-1 gag and gp120 sequences were derived from peripheral blood mononuclear cells (PBMC) of 16 infected mothers and infants, from Kisumu, Kenya. PCR, cloning, and phylogenetic analyses were conducted to examine any sequence differences between HIV-1 strains derived from mother-infant pairs.
Results:
The cohort consisted of seven pairs harboring possible subtype A/D recombinants, eight pairs with apparent pure A or D strains and one possible dual infection. This dual infection comprised of a pure subtype A region and an A/D recombinant, and was detected in one of the mother's sample. Interestingly, only the recombinant virus was detected in the paired baby sample.
Conclusions:
This study shows that HIV-1 inter-subtype recombinants can be effectively transmitted vertically to infants, and could possibly be favored in this setting where multiple subtypes infect women. Together, dual infections and the co-existence of multiple HIV-1 subtypes is encouraging the emergence of recombinant HIV strains and their rapid dispersal.
HIV type 1 sequence diversity and dual infections in Kenya.
Author: Steain, M. C.; Wang, B.; Yang, C.; Shi, Y. P.; Nahlen, B.; Lal, R. B., and Saksena, N. K.
Source: AIDS Res Hum Retroviruses. 2005 Oct; 21(10):882-5.
Abstract: As vertical transmission of HIV-1 is an ongoing problem in East Africa, we analyzed HIV-1 strains of infected mothers, from Kisumu, Kenya. We sequenced the gag and gp120 regions from peripheral blood mononuclear cells (PBMC) of 15 HIV-infected mothers attending an antenatal clinic. PCR, cloning, bootscanning, using the program Simplot, and phylogenetic analyses were conducted to assign subtypes and identify recombinants. Our analyses showed two dual infections from patients who had infections with pure subtypes and recombinants subtype D. In addition, we also noted the presence of subsubtype A1 and A2, as well as unique recombinants in this area. These results imply that the HIV epidemic in western Kenya is a dynamic one and is continually evolving. Therefore, continued monitoring of the epidemic in this region is necessary if a vaccine for the area is to be developed.
Evaluation of two commercially available alternatives for HIV-1 viral load testing in resource-limited settings.
Author: Steegen, K.; Luchters, S.; De Cabooter, N.; Reynaerts, J.; Mandaliya, K.; Plum, J.; Jaoko, W.; Verhofstede, C., and Temmerman, M.
Source: J Virol Methods. 2007 Dec; 146(1-2):178-87.
Abstract: There is an urgent need for low-cost assays for HIV-1 quantitation to ensure adequate follow-up of HIV-infected patients on antiretroviral therapy (ART) in resource-limited countries. Two low-cost viral load assays are evaluated, a reverse transcriptase activity assay (ExavirLoad v2, Cavidi) and a real-time reverse transcriptase PCR assay (Generic HIV viral load, Biocentric). Both tests were compared with the ultrasensitive HIV Amplicor Monitor assay. Samples were collected in Mombasa, Kenya, from 20 HIV-1 seronegative and 150 HIV-1 seropositive individuals of whom 50 received antiretroviral treatment (ART). The ExavirLoad and the Generic HIV viral load assay were performed in a local laboratory in Mombasa, the Amplicor Monitor assay (version 1.5, Roche Diagnostics) was performed in Ghent, Belgium. ExavirLoad and Generic HIV viral load reached a sensitivity of 98.3% and 100% and a specificity of 80.0% and 90.0%, respectively. Linear regression analyses revealed good correlations between the Amplicor Monitor and the Generic HIV viral load (r=0.935, p<0.001) with high accuracy (100.1%), good precision (5.5%) and a low percent similarity coefficient of variation (5.4%). Bland-Altman analysis found 95% of the samples within clinically acceptable limits of agreement (-1.19 to 0.87logcopies/ml). Although, the ExavirLoad also showed a good linear correlation with the Amplicor Monitor (r=0.901, p<0.001), a problem with false positive results was more significant. The cost per test remains relatively high (US$ 30 for ExavirLoad and US$ 20 for the Generic HIV viral load). Hence, false positive results and the need for an expensive PCR instrument for the Generic HIV viral load assays still limit the implementation of these tests in less equipped, less experienced laboratories.
Circumcision and HIV.
Author: Szpir M; Behrend L, and Stalker, M. S. Men's health:
Source: Mera. 2007 Mar; (28):iii-iv, vi.
Abstract: There is now clear evidence that male circumcision reduces the transmission of HIV from women to men. In December 2006, the National Institutes of Health (NIH) in the United States halted two clinical trials, in Kenya and Uganda, on the grounds that it would be unethical not to offer circumcision to all the men taking part in the studies. Circumcised men in both trials had dramatically reduced rates of HIV infection -a reduction of 53% in Kenya and 48% in Uganda-compared to controls who were uncircumcised. These results confirm a similar trial in South Africa, which showed that circumcised men were 60 % less likely to be infected with HIV during heterosexual sex. The Data Safety and Monitoring Board of the NIH stopped the South African trial during an interim analysis in 2005 and asked the clinicians to offer circumcision to the control group. (excerpt).
Taravella, S. Comprehensive care centers and antiretroviral drugs: bringing new life to Kenyans with HIV.
Abstract: A 34-year-old teacher, crying uncontrollably, was brought into Kakamega Provincial General Hospital in Kenya's Western Province in January 2004 by a relative. The teacher, who was HIV-positive, was suffering in many ways. Much of her hair had fallen out. She had pneumocystis carinii pneumonia. And tuberculosis. And a troubling skin condition. And an alarming CD-4 count of 44. And she had just lost a dear friend to AIDS. But none of this is why she was crying. She was crying because, overwhelmed by despair, she had taken leave from her job for the specific purpose of allowing herself to die. But her leave had now come to an end and she found herself still very much alive. The anguish of expecting to die but instead facing a return to work was too much for her to bear. At the hospital that day, she encountered Beth Barasa, who supervises counselors in the hospital's voluntary counseling and testing (VCT) service. Barasa spent time educating the woman about antiretroviral therapy (ART), helping her see that her life need not end now. The teacher went on ART in February 2004. By August 2004, her CD-4 count had risen to 206. She was receiving treatment for her TB, she had regained weight and even her hair had regained most of its luster. Barasa, who supported the teacher with follow-up home visits, says, "When she looks at me now, she just laughs because she had given up on life." Antiretroviral drugs (ARVs) are transforming HIV care in the developing world, and Kenyans are benefiting in profound ways. What happened to this teacher is happening across this country of more than 32 million people, a nation with an HIV infection rate of about 6.7 percent. And the U.S. Office of the Global AIDS Coordinator is playing a leadership role throughout. (excerpt)
The Kenyan workplace: a strong tool for HIV prevention and treatment.
Abstract: Zacharia Akhonya is a tall, strikingly handsome 29-year-old with a captivating smile. He makes his living as a Boda Boda driver, the local term for the young men who transport residents of Kakamega about town on the rear of bicycles. But Akhonya sees each passenger encounter as more than a source of income; it's an opportunity to educate and inform. From the front of his bicycle, cars whizzing past him on Kakamega's dusty roads, he talks with his passengers about AIDS. Discussing matters such as HIV testing and proper condom use, he has turned his job into a mechanism for helping his neighbors maintain their own health. Akhonya is one of about 200 Boda Boda drivers who have completed a five-day, peer-education training program on HIV/AIDS since October 2003, enabling them to spread prevention messages in the towns of Bungoma, Busia, Kakamega, Mumias, Nzoia and Webuye. The Boda Boda effort is one of many peer-education programs funded by the U.S. Agency for International Development (USAID) that use Kenyan work settings to increase AIDS knowledge, reduce AIDS stigma, and improve services to those who are HIV-positive. These programs have grown from simple awareness efforts to comprehensive programs that in some cases even provide life-saving antiretroviral drugs (ARVs). (excerpt)
Food and nutrition implications of antiretroviral therapy (ART) in Kenya. A formative assessment.
Author: Thuita, F. M.
Source: Final report.
Abstract: Kenya is one of the 15 countries scaling up HIV/AIDS programs with support from the President's Emergency Plan for AIDS Relief (PEPFAR). Due to the interactions that can occur between ART and food and nutrients, managing nutritional implications of ART is an important component in the success of ART services in resource limited settings. Nutrition interventions in the context of ART focus on assisting PHA and caregivers to make dietary choices that manage drug side effects and promote drug efficacy and adherence. This formative assessment was undertaken to increase understanding of the food and nutrition needs of clients on ART and the kind of messages that may be needed by service providers to integrate nutrition in ART care. It is anticipated that the findings of this report will facilitate incorporation of relevant nutrition content into ART management training materials in Kenya and will inform the development of tools and materials to support effective nutritional counseling of ART clients. The study was conducted by a consultant in partnership with a team from NASCOP. The study was carried out in 5 sites - Nairobi, Thika, Kiambu, Eldoret and Mombasa - at government and nongovernment health facilities and other programs providing ART. A total of 13 facilities in the 5 sites including public, private and mission hospitals, as well as NGOs and networks of PHA were visited. A combination of systematic formative research methods were utilized including focus group discussions, in-depth key informant interviews, case studies, and expert informational meetings. (excerpt)
Community-Based HIV / AIDS Prevention, Care and Support Program.
Author: Thurman, T. R.; . = Hoffman A; Chatterji M, and Brown L.
Source: A case study.
Abstract: An estimated 12 million children aged 17 and under have lost one or both parents to AIDS in sub-Saharan Africa. Despite recognition of the magnitude and negative consequences of this problem, there is little evidence on "what works" to improve the well being of children affected by HIV and AIDS. In an attempt to fill this knowledge gap, MEASURE Evaluation is conducting targeted evaluations of five programs for orphans and vulnerable children (OVC) in five unique settings - two in Kenya and three in Tanzania. Case studies are the first phase of MEASURE Evaluation's targeted evaluations and begin the process of information sharing on lessons learned in programming for OVC. Additional evaluation activities under the MEASURE Evaluation targeted evaluation activity include an impact assessment and costing activity of each of the five selected programs. This case study was conducted to impart a thorough understanding of U.S. Pathfinder in Kenyal's OVC program model and to document lessons learned that could be applied to other initiatives. This case study is based upon a program document review; program site visits, including discussions with local staff, volunteers, beneficiaries and community members; as well as observations of program activities. The primary audience for this case study includes OVC program implementers in Kenya and elsewhere in Africa, as well as relevant policymakers and funding agencies addressing OVC needs. (excerpt)
Kilifi Orphans and Vulnerable Children Project.
Source: A case study.
Abstract: This case study was conducted to impart a thorough understanding of Catholic Relief Services' (CRS) OVC program model in Kenya and to document lessons learned that could be applied to other OVC initiatives. This case study is based upon a program document review; program site visits, including discussions with local staff, volunteers, beneficiaries and community members; as well as observations of program activities. The primary audience for this case study includes OVC program implementers in Kenya and elsewhere in Africa, as well as relevant policy makers and funding agencies addressing OVC needs. The Kilifi OVC project of CRS was selected as a priority program for the evaluation. Program goals are to: increase the capacity of communities and families and orphans to respond to the needs of OVC; and increase the institutional capacity of local partners to deliver high quality and sustainable interventions. (excerpt)
Integrated AIDS program, Thika, Kenya.
Author: Thurman, T. R. and . = Neudorf K.
Source: A case study.
Abstract: The purpose of this case study is to gain a better understanding of one of the programs selected for the evaluation - Integrated AIDS Program-Thika (IAPThika) supported by Pathfinder International - as well as identify lessons learned that could be applied to other initiatives. The case study is based upon program document review; program site visits, including discussions with local staff, volunteers, beneficiaries, and community members; and observations of program activities. The primary audience for this case study includes OVC program implementers in Kenya and elsewhere in Africa, as well as relevant policy makers, funding agencies addressing OVC needs, and other local and international stakeholders. (excerpt)
Effects of HIV/AIDS on maternity care providers in Kenya.
Author: Turan, J. M.; Bukusi, E. A.; Cohen, C. R.; Sande, J., and Miller, S.
Source: J Obstet Gynecol Neonatal Nurs. 2008 Sep-2008 Oct 31; 37(5):588-95.
Abstract: Objective:
To explore the impact of HIV/AIDS on maternity care providers in labor and delivery in a high HIV-prevalence setting in sub-Saharan Africa.
Design:
Qualitative one-on-one in-depth interviews with maternity care providers.
Setting:
Four health facilities providing labor and delivery services (2 public hospitals, a public health center, and a small private maternity hospital) in Kisumu, Nyanza Province, Kenya.
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