Pre-exposure prophylaxis uptake concerns in the Democratic Republic of the Congo: Key population and healthcare workers perspectives.

Key populations (KP) in the Democratic Republic of the Congo (DRC), including female sex workers (SW), are disproportionally affected by HIV. Quantitative feedback surveys were conducted at seven health facilities in DRC with 70 KP clients enrolled in pre-exposure prophylaxis (PrEP) services to measure benefits and concerns. The surveys also assessed satisfaction with PrEP services and experiences of stigma at the health facilities. Thirty healthcare workers (HCW) were surveyed to measure attitudes, beliefs, and acceptability of providing services to KP. KP client survey participants were primarily female SW. KP clients reported that the primary concern about taking PrEP was fear of side effects (67%) although few KP reported having experienced side effect (14%). HCW concurred with clients that experienced and anticipated side effects were a primary PrEP uptake concern, along with costs of clinic visits.

HIV, syphilis, and hepatitis B virus infection and male circumcision in five Sub-Saharan African countries: Findings from the Population-based HIV Impact Assessment surveys, 2015-2019.

Voluntary medical male circumcision (VMMC) has primarily been promoted for HIV prevention. Evidence also supports that male circumcision offers protection against other sexually transmitted infections. This analysis assessed the effect of circumcision on syphilis, hepatitis B virus (HBV) infection and HIV. Data from the 2015 to 2019 Population-based HIV Impact Assessments (PHIAs) surveys from Rwanda, Tanzania, Uganda, Zambia, and Zimbabwe were used for the analysis. The PHIA surveys are cross-sectional, nationally representative household surveys that include biomarking testing for HIV, syphilis and HBV infection. This is a secondary data analysis using publicly available PHIA data. Univariate and multivariable logistic regression models were created using pooled PHIA data across the five countries to assess the effect of male circumcision on HIV, active and ever syphilis, and HBV infection among sexually active males aged 15-59 years. Circumcised men had lower odds of syphilis infection, ever or active infection, and HIV, compared to uncircumcised men, after adjusting for covariates (active syphilis infection = 0.67 adjusted odds ratio (aOR), 95% confidence interval (CI), 0.52-0.87, ever having had a syphilis infection = 0.85 aOR, 95% CI, 0.73-0.98, and HIV = 0.53 aOR, 95% CI, 0.47-0.61). No difference between circumcised and uncircumcised men was identified for HBV infection (P = 0.75). Circumcised men have a reduced likelihood for syphilis and HIV compared to uncircumcised men. However, we found no statistically significant difference between circumcised and uncircumcised men for HBV infection.

Pre-exposure prophylaxis (PrEP) uptake and service delivery adaptations during the first wave of the COVID-19 pandemic in 21 PEPFAR-funded countries.

BACKGROUND: Mitigation measures for the first wave of the COVID-19 pandemic and burden on health systems created challenges for pre-exposure prophylaxis (PrEP) service delivery. We examined PrEP uptake in PEPFAR programs before and after the start of the COVID-19 pandemic. METHODS: We studied two PEPFAR program monitoring indicators, using routine Monitoring, Evaluation, Reporting (MER) indicators capturing uptake of PrEP (PrEP_NEW) and overall use of PrEP (PrEP_CURR). We also analyzed descriptive program narratives to understand successes and challenges field teams encountered after the start of the COVID-19 pandemic. To assess changes in coverage of PrEP across 21 countries, we calculated the "PrEP to need ratio" (PnR) using a published methodology. We defined the pre-COVID time period as April 1, 2019 -March 31, 2020 and the COVID time period as April 1, 2020 -March 31, 2021. FINDINGS: The total number of persons who initiated PrEP increased by 157% from 233,250 in the pre-COVID-19 period compared with 599,935 in the COVID-19 period. All countries, except five, noted significant increases in PrEP uptake. PrEP uptake among adolescent girls and young women (AGYW) increased by 159% from 80,452 AGYW in the pre-COVID-19 period to 208,607 AGYW in the COVID-19 period. There were 77,430 key populations (KP) initiated on PrEP in the pre-COVID-19 period and 209,114 KP initiated in the COVID-19 period (a 170% increase). The PnR increased 214% in the COVID-19 period across all PEPFAR-supported countries. Adaptations, such as multi-month dispensing (MMD) of PrEP; virtual demand creation activities; decentralized, community-based and virtual service delivery, were implemented to maintain PrEP services. CONCLUSIONS: PEPFAR programs continued to maintain and initiate new clients on PrEP despite the challenges posed by the COVID-19 pandemic. Adaptations such as MMD of PrEP and use of technology were vital in expanding service delivery and increasing PrEP coverage. FUNDING: This project has been supported by the U.S. President's Emergency Plan for AIDS Relief.

PrEP for key populations: results from the first PrEP demonstration project in the Democratic Republic of the Congo.

Oral pre-exposure prophylaxis (PrEP) is recommended for persons at substantial risk for HIV, including female sex workers (FSW), men who have sex with men (MSM), people who inject drugs (PWID), and transgender women (TGW). We report on a PrEP demonstration project at seven clinics in the Democratic Republic of the Congo. Routinely collected data were abstracted to assess PrEP uptake, scheduled visit attendance, and self-reported adherence. Between February and May 2018, 469 eligible clients were offered daily oral PrEP; 75.1% accepted: 78.7% FSW, 20.5% MSM, and 0.9% TGW. Two percent also identified as PWID. Attendance was 64.5% at one-month visits; 82.1% at three-month visits; and among 47.7% of clients who initiated PrEP at least six months before data abstraction, 85.8% at six-month visits. Among 66.3% of clients with at least one adherence assessment, 39% self-reported low adherence. Results demonstrate the acceptability of PrEP delivered in healthcare settings serving FSW, MSM, PWID, and TGW.

Enrolment characteristics associated with retention among HIV negative Kenyan gay, bisexual and other men who have sex with men enrolled in the Anza Mapema cohort study.

INTRODUCTION: Most gay, bisexual and other men who have sex with men (GBMSM) live in rights-constrained environments making retaining them in research to be as hard as recruiting them. To evaluate Anza Mapema, an HIV risk-reduction programme in Kisumu, Kenya, we examined the enrolment sociodemographic, behavioural, psychosocial and clinical factors associated with missing two or more follow-up visits for GBMSM participating in Anza Mapema. METHODS: Between August 2015 and November 2017, GBMSM were enrolled and followed in a prospective cohort study with quarterly visits over 12 months. At enrolment, men were tested for HIV and sexually transmitted infections and completed questionnaires via audio computer-assisted self-interview. Because the Kenya Ministry of Health recommends HIV testing every three to six months for GBMSM, the retention outcome in this cross sectional analysis was defined as missing two consecutive follow-up visits (vs. not missing two or more consecutive visits). Multivariable logistic regression estimated the adjusted odds ratios (aOR) and 95% confidence intervals (CI) for the associations of the enrolment characteristics with the binary outcome of retention. RESULTS AND DISCUSSION: Among 609 enrolled HIV-negative GBMSM, the median age was 23 years (interquartile range, 21 to 28 years), 19.0% had completed ≤8 years of education and 4.1% had resided in the study area <1 year at enrolment. After enrolment, 19.7% missed two consecutive follow-up visits. In the final multivariable model, the odds of missing two consecutive follow-up visits were higher for men who: resided in the study area <1 year at enrolment (aOR, 4.14; 95% CI: 1.77 to 9.68), were not living with a male sexual partner (aOR, 1.59; 95% CI: 1.01 to 2.50), and engaged in transactional sex during the last three months (aOR, 1.70; 95% CI: 1.08 to 2.67). CONCLUSIONS: One in five men missed two consecutive follow-up visits during this HIV prevention study despite intensive retention efforts and compensation for travel and participation. Participants with recent community arrival may require special support to optimize their retention in HIV prevention activities. Live-in partners of participants may be enlisted to support greater engagement in prevention programmes, and men who engage in transactional sex will need enhanced counselling and support to stay in longitudinal studies.

Expansion of HIV Preexposure Prophylaxis to 35 PEPFAR-Supported Early Program Adopters, October 2016-September 2018.

The U.S. President's Emergency Plan for AIDS Relief (PEPFAR), the largest bilateral funder of human immunodeficiency virus (HIV) prevention and control programs worldwide, currently supports implementation of preexposure prophylaxis (PrEP) to reduce HIV incidence among persons at substantial risk for infection, including female sex workers, men who have sex with men (MSM), and transgender women (hereafter referred to as key populations). Recent estimates suggest that 54% of all global new HIV infections in 2018 occurred among key populations and their sexual partners (1). In 2016, PEPFAR began tracking initiation of PrEP by key populations and other groups at high risk (2). The implementation and scale-up of PrEP programs across 35 PEPFAR-supported country or regional programs* was assessed by determining the number of programs reporting any new PrEP clients during each quarter from October 2016 to September 2018. As of September 2018, only 15 (43%) PEPFAR-supported country or regional programs had implemented PrEP programs; however, client volume increased by 3,351% over the assessment period in 15 country or regional programs. Scale-up of PrEP among general population clients (5,255%) was nearly three times that of key population clients (1,880%). Among key populations, the largest increase (3,518%) occurred among MSM. Factors that helped drive the success of these PrEP early adopter programs included initiation of national, regional, and multilateral stakeholder meetings; engagement of ministries of health and community advocates; revision of HIV treatment guidelines to include PrEP; training for HIV service providers; and establishment of drug procurement policies. These best practices can help facilitate PrEP implementation, particularly among key populations, in other country or regional programs to reduce global incidence of HIV infection.

Incident gonorrhoea and chlamydia among a prospective cohort of men who have sex with men in Kisumu, Kenya.

OBJECTIVE: STIs disproportionately affect men who have sex with men (MSM) in sub-Saharan Africa. We identified factors associated with incident Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) infections among MSM in the Anza Mapema cohort study in Kisumu, Kenya. METHODS: We enrolled 711 MSM who underwent HIV testing and counselling, medical history and examination, and collection of demographic and behavioural information. They also provided urine and rectal swab specimens for CT and NG testing by qualitative PCR at baseline and at months 6 and 12. Separate multivariable Cox regression models identified factors associated with first incident urethral or rectal infection. RESULTS: Among the 619 men aged 18-54 years included in this analysis, there were 83 first incident urethral CT/NG infections (14.4 cases per 100 person-years (PY)) and 40 first incident rectal infections (6.84 cases per 100 PY), and an overall incidence of 18.0 cases per 100 PY (95% CI 14.8 to 21.8). Most urethral (84%) and rectal (81%) infections were asymptomatic. In the adjusted model, the risk of first incident urethral CT/NG decreased by 4% for each 1-year increase in age and was 41% lower for men who reported their partner used condom at last sexual encounter. Men who were HIV-positive had a 68% less risk of urogenital CT/NG compared with those who were negative. Men who reported being usually receptive or versatile as compared with usually insertive had an 81% increased risk of incident urogenital CT/NG. CONCLUSION: Our study demonstrated a high incidence of urethral CT/NG infection, with somewhat lower incidence of rectal CT/NG infection, despite repeated testing and treatment, highlighting the need for preventive interventions to decrease the burden of CT/NG among Kenyan MSM. Most infections were asymptomatic, and routine aetiological screening for STIs is recommended.

Prevalence and correlates of and a risk score to identify asymptomatic anorectal gonorrhoea and chlamydia infection among men who have sex with men in Kisumu, Kenya.

OBJECTIVES: In settings where laboratory capacity is limited, the WHO recommends presumptive treatment for Neisseria gonorrhoeae (NG) and Chlamydia trachomatis (CT) in asymptomatic men who have sex with men (MSM) at high risk for these infections. However, little is known about how best to target this intervention. We aimed to identify correlates of anorectal NG/CT infection in Kenyan MSM with and without anorectal symptoms and evaluate the performance of an empirical, model-based risk score to identify cases in asymptomatic men. METHODS: Anorectal NG/CT infections were diagnosed by the Abbott RealTime NG/CT nucleic acid amplification testamong 698 MSM at enrolment into the Anza Mapema study. Multivariable logistic regression was used to identify correlates of anorectal NG/CT infection in men with and without anorectal symptoms. Using coefficients from the final multivariable model for asymptomatic men, we calculated a risk score for each participant. Risk score performance was determined by calculating the sensitivity, specificity and number needed to treat (NNT) to identify one NG/CT infection. RESULTS: Overall anorectal NG/CT infection prevalence was 5.2% (n=36), of which 58.3% (n=21) were asymptomatic. Factors associated with anorectal NG/CT infection in asymptomatic men were aged 18-24 years (aOR=7.6; 95% CI: 1.7 to 33.2), HIV positive serostatus (aOR=6.9; 95% CI: 2.2 to 21.6) and unprotected anal sex in the past 3 months (aOR=3.8; 95% CI: 1.2 to 11.9). Sensitivity and specificity were optimal (81.0% and 66.1%, respectively) at a model-derived risk score cut-point ≥3, and the NNT was 12. CONCLUSIONS: A model-derived risk score based on correlates of anorectal NG/CT infection in asymptomatic participants would be sensitive and efficient (i.e, low NNT) for targeting presumptive treatment. If validated in other settings, this risk score could improve on the WHO algorithm and help reduce the burden of asymptomatic anorectal NG/CT infections among MSM in settings where diagnostic testing is not available.

Factors associated with viral suppression among HIV-positive Kenyan gay and bisexual men who have sex with men.

The UNAIDS 90-90-90 target has prioritized achieving high rates of viral suppression. We identified factors associated with viral suppression among HIV-positive gay, bisexual, and other men who have sex with men (GBMSM) in Kisumu, Kenya. HIV-positive participants in the Anza Mapema study were offered antiretroviral therapy (ART) regardless of CD4 count. HIV viral load was assessed at baseline and after 6 and 12 months of follow-up. Viral suppression was defined as <1,000 copies/mL. Sociodemographic, sexual behaviors, and psychosocial characteristics were assessed via audio computer-assisted self interview. We used generalized estimating equations to estimate the associations between baseline and time-dependent predictors and viral suppression at 6 and 12 months. Seventy-five HIV-positive men were enrolled in the Anza Mapema study, of which 63 had at least one viral load measured during follow-up. Among 52 men with a viral load measure at month 6, 37 (71%) were on ART and virally suppressed. Among 59 men with a viral load measure at month 12, 37 (63%) were on ART and virally suppressed. In the final multivariable model, men who reported receptive or versatile sexual position during anal intercourse with a male partner had reduced odds of viral suppression (aOR = 0.20; 95% CI: 0.08-0.50). Greater levels of coping self-efficacy were associated with increased odds of viral suppression (aOR = 1.10; 95% CI: 1.03-1.16). Despite extensive initiation, retention, and adherence support, the rate of viral suppression in this population did not meet the UNAIDS 90-90-90 target (81% for individuals aware of their HIV status). Pervasive stigma against male-male sex, especially men who practice receptive anal sex, may underlie our findings, which highlight the need for advocacy and stigma reduction efforts. Because coping self-efficacy was a protective factor, efforts to promote resilience in addition to healthy sexual identity development may lead to improved care outcomes among GBMSM in this area.

Prevalence and Correlates of Genital Infections Among Newly Diagnosed Human Immunodeficiency Virus-Infected Adults Entering Human Immunodeficiency Virus Care in Windhoek, Namibia.

BACKGROUND: Identifying and treating genital infections, including sexually transmitted infections (STI), among newly diagnosed human immunodeficiency virus (HIV)-infected individuals may benefit both public and individual health. We assessed prevalence of genital infections and their correlates among newly diagnosed HIV-infected individuals enrolling in HIV care services in Namibia. METHODS: Newly diagnosed HIV-infected adults entering HIV care at 2 health facilities in Windhoek, Namibia, were recruited from December 2012 to March 2014. Participants provided behavioral and clinical data including CD4+ T lymphocyte counts. Genital and blood specimens were tested for gonorrhea, Chlamydia, trichomoniasis, Mycoplasma genitalium, syphilis, bacterial vaginosis, and vulvovaginal candidiasis. RESULTS: Among 599 adults, 56% were women and 15% reported consistent use of condoms in the past 6 months. The most common infections were bacterial vaginosis (37.2%), trichomoniasis (34.6%) and Chlamydia (14.6%) in women and M. genitalium (11.4%) in men. Correlates for trichomoniasis included being female (adjusted relative risk, [aRR], 7.18; 95% confidence interval [CI], 4.07-12.65), higher education (aRR, 0.58; 95% CI, 0.38-0.89), and lower CD4 cell count (aRR, 1.61; 95% CI, 1.08-2.40). Being female (aRR, 2.39; 95% CI, 1.27-4.50), nonmarried (aRR, 2.30; (95% CI, 1.28-4.14), and having condomless sex (aRR, 2.72; 95% CI, 1.06-7.00) were independently associated with chlamydial infection. Across all infections, female (aRR, 2.31; 95% CI, 1.79-2.98), nonmarried participants (aRR, 1.29; 95% CI, 1.06-1.59), had higher risk to present with any STI, whereas pregnant women (aRR, 1.16, 95% CI 1.03-1.31) were at increased risk of any STI or reproductive tract infection.

Genital infections and syndromic diagnosis among HIV-infected women in HIV care programmes in Kenya.

Control of genital infections remains challenging in most regions. Despite advocacy by the World Health Organization for syndromic case management, there are limited data on the syndromic approach, especially in HIV care settings. This study compared the syndromic approach with laboratory diagnosis among women in HIV care in Kenya. A mobile team visited 39 large HIV care programmes in Kenya and enrolled participants using population-proportionate sampling. Participants provided behavioural and clinical data with genital and blood specimens for lab testing. Among 1063 women, 68.4% had been on antiretroviral therapy >1 year; 58.9% were using cotrimoxazole prophylaxis; 51 % had CD4+T-lymphocytes < 350 cells/µL. Most women (63.1%) reported at least one genital symptom. Clinical signs were found in 63% of women; and 30.8% had an aetiological diagnosis. Bacterial vaginosis (17.4%), vaginal candidiasis (10.6%) and trichomoniasis (10.5%) were the most common diagnoses. Using laboratory diagnoses as gold standard, sensitivity and positive predictive value of the syndromic diagnosis for vaginal discharge were 47.6% and 52.7%, respectively, indicating a substantial amount of overtreatment. A systematic physical examination increased by 9.3% the positive predictive value for genital ulcer disease. Women attending HIV care programmes in Kenya have high rates of vaginal infections. Syndromic diagnosis was a poor predictor of those infections.

Re-Testing and Seroconversion Among HIV Testing and Counseling Clients in Lesotho.

HIV testing and counseling (HTC) is an essential component of comprehensive HIV programs. Retrospective HTC program data from 2006 to 2010 were examined to determine patterns of re-testing and seroconversion in Lesotho. Among 104,662 initially negative clients, 6,777 (6.5%) were re-testers. Predictors of re-testing included being male, age ≥ 25 years, divorced/separated, having more than a high school education, being tested as a couple, testing in the year 2006, testing in the capital city, and awareness of partner's recent testing behavior. Among re-testers who seroconverted (N = 259), predictors included being female and having less than a high school education. There is a critical need for more effectively targeting HIV retesting messages to align with WHO (2010) guidelines and identify persons at highest risk for HIV, to increase timely diagnoses and link persons to appropriate HIV prevention, care, and treatment services.

HIV epidemic among key populations in west Africa.

PURPOSE OF REVIEW: Globally, HIV infection remains a significant issue for key populations such as men who have sex with men (MSM) and female sex workers. A review of recent articles was conducted for west African countries to assess the burden of disease among female sex workers and MSM, access to services and identify barriers to implementation of services for key populations. RECENT FINDINGS: In west Africa, key populations engage in high-risk practices for the acquisition of HIV and other sexually transmitted infections. Available HIV prevalence data fluctuate across and within countries for both MSM and female sex workers and may be five to ten times as high as that of the general population. HIV prevalence varied from 15.9% in The Gambia to 68% in Benin among female sex workers, whereas it ranged from 9.8% in The Gambia to 34.9% in Nigeria for MSM. Yet, important data gaps exist, including key populations size estimations in several countries as well as HIV prevalence, incidence and other biomarkers of HIV risk. Because of sociocultural, legal, political and economic challenges, exacerbated by a poor health system infrastructure, the HIV response is not strategically directed toward programs for key populations in countries with concentrated epidemics. Noteworthy is the low coverage of prevention care and treatment interventions offered to key populations. SUMMARY: Sufficient planning and political will with legal and structural frameworks that reconcile public health and human rights are needed to prioritize HIV prevention, care and treatment programming for key populations programs in west Africa.

Sexually transmitted infections among HIV-infected adults in HIV care programs in Kenya: a national sample of HIV clinics.

BACKGROUND: Identifying sexually transmitted infections (STI) in HIV-infected individuals has potential to benefit individual and public health. There are few guidelines regarding routine STI screening in sub-Saharan African HIV programs. We determined sexual risk behavior and prevalence and correlates of STI in a national survey of large HIV treatment programs in Kenya. METHODS: A mobile screening team visited 39 (95%) of the 42 largest HIV care programs in Kenya and enrolled participants using population-proportionate systematic sampling. Participants provided behavioral and clinical data. Genital and blood specimens were tested for trichomoniasis, gonorrhea, chlamydia, syphilis, and CD4 T-lymphocyte counts. RESULTS: Among 1661 adults, 41% reported no sexual partners in the past 3 months. Among those who reported sex in the past 3 months, 63% of women reported condom use during this encounter compared with 77% of men (P < 0.001). Trichomoniasis was the most common STI in women (10.9%) and men (2.8%); prevalences of gonorrhea, chlamydia, and syphilis were low (<1%-2%). Among women, younger age (adjusted odds ratio [OR], 0.96 per year; 95% confidence interval [CI], 0.94-0.98) and primary school education or lower level (adjusted OR, 2.16; 95% CI, 1.37-3.40) were independently associated with trichomoniasis, whereas CD4 count, cotrimoxazole use, and reported condom use were not. Reported condom use at last sex was associated with reporting that the clinic provided condoms among both women (OR, 1.7; 95% CI, 1.17-2.35) and men (OR, 2.4; 95% CI, 1.18-4.82). CONCLUSIONS: Women attending Kenyan HIV care programs had a 10.9% prevalence of trichomoniasis, suggesting that screening for this infection may be useful. Condom provision at clinics may enhance secondary HIV prevention efforts.

The HVTN protocol 903 vaccine preparedness study: lessons learned in preparation for HIV vaccine efficacy trials.

Successful recruitment and retention of HIV-uninfected at-risk participants are essential for HIV vaccine efficacy trials. A multicountry vaccine preparedness study was started in 2003 to assess enrollment and retention of HIV-negative high-risk participants and to assess their willingness to participate in future vaccine efficacy trials. HIV-negative high-risk adults were recruited in the Caribbean, in Southern Africa, and in Latin America, and were followed for 1 year. Participants included men who have sex with men, heterosexual men and women, and female sex workers. History of sexually transmitted infections and sexual risk behaviors were recorded with HIV testing at 0, 6, and 12 months, and willingness to participate in future vaccine trials was recorded at 0 and 12 months. Recruitment, retention, and willingness to participate in future trials were excellent at 3 of the 6 sites, with consistent declines in risk behaviors across cohorts over time. Although not powered to measure seroincidence, HIV seroincidence rates per 100 person-years (95% confidence interval [CI]) were as follows: 2.3 (95% CI: 0.3 to 8.2) in Botswana, 0.5 (95% CI: 0 to 2.9) in the Dominican Republic, and 3.1 (95% CI: 1.1 to 6.8) in Peru. The HIV Vaccine Trials Network 903 study helped to develop clinical trial site capacity, with a focus on recruitment and retention of high-risk women in the Americas, and improved network and site expertise about large-scale HIV vaccine efficacy trials.

Viral load and CD4 count dynamics after HIV-1 seroconversion in homosexual and bisexual men in Rio de Janeiro, Brazil.

PURPOSE: Reliable predictors of HIV disease progression are scarce in developing countries, where most HIV infections occur. We describe early virologic and immunologic events among men who have sex with men in Rio de Janeiro, Brazil. METHODS: Seroconverters from 2 high-risk cohorts were followed for up to 36 months with periodic laboratory evaluations, plasma viral load, and CD4 count assessments. Viral load and CD4 count mean trajectories were computed. For the modeled viral loads, mean and median values were 24,480 (4.36 log10) and 19,720 (4.29 log10) copies/mL (range 14,880-58,090), respectively. Median CD4 count was 373 cells/microL (range 260-508). Overall variation on viral loads ranged from 4.3 to 5.2 log10 copies/mL with a visible increase in the viral load starting at approximately 600 days (n = 12) after estimated time of seroconversion. The initial period of HIV infection was characterized by an increase in CD4 count (n = 29) followed by a steep decline starting at approximately 200 days (508 cells, 95% CI: 425 to 569). A gradual decrease was observed in the median CD4 count thereafter, reaching 281 (95% CI: 100 to 466) at 1000 days after the estimated date of seroconversion. CONCLUSIONS: Although viral load dynamics resembled those observed in developed countries, CD4 counts seem to decline at a faster rate than in the Multicenter AIDS Cohort Study (MACS) cohort. Clinical and survival data are needed to assess the impact of interventions, such as antiretroviral therapy, on the clinical course of HIV infection in Brazil.

Enrollment of racial/ethnic minorities in NIAID-funded networks of HIV vaccine trials in the United States, 1988 to 2002.

OBJECTIVE: The purpose of this study was to analyze enrollment of racial/ethnic minorities in Phase I and Phase II HIV vaccine trials in the U.S. conducted by National Institute of Allergy and Infectious Diseases (NIAID)-funded networks from 1988 to 2002. METHODS: A centralized database was searched for all NIAID-funded networks of HIV vaccine trial enrollment data in the U.S. from 1988 through 2002. The authors reviewed data from Phase I or Phase II preventive HIV vaccine trials that included HIV-1 uninfected participants at low to moderate or high risk for HIV infection based on self-reported risk behaviors. Of 66 identified trials, 55 (52 Phase I, 3 Phase II) met selection criteria and were used for analyses. Investigators extracted data on participant demographics using statistical software. RESULTS: A total of 3,731 volunteers enrolled in U.S. NIAID-funded network HIV vaccine trials from 1988 to 2002. Racial/ethnic minority participants represented 17% of the overall enrollment. By pooling data across all NIAID-funded networks from 1988 to 2002, the proportion of racial/ethnic minority participants was significantly greater (Fisher's exact test p-value < 0.001) in Phase II trials (278/1,061 or 26%) than in Phase I trials (347/2,670 or 13%). By generalized estimating equations, the proportion of minorities in Phase I trials increased over time (p = 0.017), indicating a significant increase in racial/ethnic minority participants from 1988 to 2002. CONCLUSIONS: There has been a gradual increase in racial/ethnic minority participation in NIAID-funded network HIV vaccine trials in the U.S. since 1988. In the light of recent efficacy trial results, it is essential to continue to increase the enrollment of diverse populations in HIV vaccine research.

Virologic and immunologic outcomes and programmatic challenges of an antiretroviral treatment pilot project in Abidjan, Côte d'Ivoire.

BACKGROUND: In Côbte d'Ivoire, a pilot project was developed by UNAIDS and the Ministry of Health to improve access to AIDS care, including antiretroviral therapy, for adults and children infected with HIV. This evaluation of the project is the first to provide results of a large number of HIV-infected patients receiving antiretroviral therapy in West Africa. METHODS: We evaluated records of persons who presented for care from August 1998 to August 2000 at six accredited centers in Abidjan. Patients were treated with two nucleoside reverse transcriptase inhibitors (2NRTI) or highly active antiretroviral therapy (HAART). RESULTS: Of 2878 patients who were screened, 2351 (83%) were HIV-infected and eligible (CD4 T lymphocyte count < 500 x 10(6) cells/l or plasma HIV-RNA level > 10 000 copies/ml) for antiretroviral therapy. Of those who were eligible, 81% were symptomatic, 63% had a CD4 cell count < 200 x 10(6) cells/l, 12% had previously taken antiretroviral drugs, and 56% returned to the clinic for follow-up. Of the patients screened, 768 (27%) were started on antiretroviral therapy, including 450 on HAART, 296 on 2NRTI, and 22 on other regimens. We analyzed data from 480 HIV-1-infected adults, who were naive to therapy, were prescribed HAART or 2NRTI, and had at least one clinic visit after starting therapy. In an intent-to-treat analysis of patients who received HAART, the estimated plasma HIV-1 RNA level was approximately 1.9 log10 copies/ml (80-fold) lower, while estimated CD4 cell count was > 100 x 10(6) cells/l higher than baseline values, after 1 year of therapy. Approximately 25% of adults on 2NRTI and 50% of those on HAART had < 200 copies/ml, after 1 year of therapy. The probability of an adverse event occurring within 6 months after starting therapy was 0.20. The probability of survival for at least 1 year was 0.84 (95% confidence interval, 0.80-0.89). CONCLUSION: After starting antiretroviral therapy, these HIV-1-infected patients in West Africa had similar virologic and immunologic outcomes, probability of an adverse event, and estimated survival, as patients enrolled in clinical trials in the USA and Europe. However, only one-third of eligible patients received therapy, highlighting the importance of providing adequate education and support for initiating and adhering to therapy in this and similar programmes.

A pilot study of treatment of Buruli ulcer with rifampin and dapsone.

OBJECTIVE: Buruli ulcer disease (BU), caused by Mycobacterium ulcerans, is endemic in many regions of Africa and causes substantial physical disability. Surgical resection, currently the mainstay of clinical management of BU, is impractical in many endemic areas. Therefore, the study was undertaken to evaluate an antibiotic regimen for medical management of BU. METHODS: A randomized, placebo-controlled pilot study of dapsone plus rifampin versus placebo was conducted. RESULTS: Forty-one participants were recruited in a BU-endemic zone of Côte d'Ivoire. Thirty persons completed the 2-month trial: 15 were treated with placebo and 15 with dapsone and rifampin. On blinded evaluation of photographs of the ulcers, clinicians with experience examining BU judged that 82% of ulcers in the treatment group improved compared with 75% in the placebo group (P=0.51). The median change in ulcer size was a decrease of 14.0 cm2 in the treatment group and a decrease of 2.5 cm2 in the placebo group (P=0.02), but initial ulcer sizes were larger in the treatment group (median 26.2 cm2) compared with the placebo group (median 4.8 cm2) (P=0.04). CONCLUSIONS: Results of this study indicate that larger studies of antimycobacterial therapy of BU are warranted and can be successfully undertaken.