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

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

Roll-out of first HIV pre-exposure prophylaxis services in the Democratic Republic of the Congo

Background: In the Democratic Republic of the Congo (DR Congo), HIV prevalence is highest in key populations, specifically female sex workers and men who have sex with men, with estimates of 7% and 18%, respectively, compared with 1·2% in the general population. Pre-exposure prophylaxis (PrEP) is an evidence-based intervention to reduce HIV incidence in populations who are at substantial risk of acquiring HIV. Building the capacity of clinics and outreach programmes serving key populations is a critical first step in scaling-up PrEP services. Here, we describe a programme from the DR Congo's National AIDS Control Programme, US Centers for Disease Control and Prevention (CDC), and ICAP at Columbia University to initiate 350 clients from key population on PrEP in 2018. Methods: With support from the National AIDS Control Programme and CDC, ICAP facilitated PrEP implementation at seven HIV care and treatment facilities in DR Congo. Capacity-building activities included: guidance on national planning; establishment of a national PrEP technical working group; and the development of PrEP training material for multidisciplinary facility teams to provide and monitor PrEP services. Training addressed: PrEP eligibility screening, initiation, and follow-up; PrEP retention and follow-up activities; and monitoring and evaluation of PrEP services. ICAP also provided ongoing on-site mentorship of clinic staff, and continuous evaluation of clinic procedures to ensure standardised PrEP service delivery across all facilities. Findings: By February, 2018, 38 clinical staff and 48 peer outreach workers had completed a 6-day PrEP training course using ICAP's PrEP training curriculum; participant and facilitator manuals; job aids; and monitoring, evaluation, and reporting tools. Following the training, four sites in Kinshasa and three sites in Lubumbashi initiated PrEP services for the first time, resulting in successful achievement of the national PrEP targets. Interpretation: Collaboration between national and global stakeholders resulted in the successful introduction of PrEP in DR Congo. PrEP implementation required extensive clinic training, tailoring of existing outreach activities to improve PrEP retention, inclusion of peer workers to help educate patients about PrEP, comprehensive monitoring and evaluation reporting, and ongoing mentoring of clinic staff. Lessons learned in DR Congo will be shared with other programmes in African countries that work with populations at risk of HIV. Project findings will also support the endorsement of national PrEP guidelines and the scale-up of PrEP in DR Congo. Funding: US Centers for Disease Control and Prevention

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