US President's Emergency Plan Research Articles

Prioritizing Mental Health within HIV and Tuberculosis Services in PEPFAR.

Underprioritization of mental health is a global problem and threatens the decades-long progress of the US President's Emergency Plan for AIDS Relief (PEPFAR) program. In recent years, mental health has become globally recognized as a part of universal healthcare, making this an opportune moment for the global community to integrate mental health services into routine programming. PEPFAR is well positioned to lead by example. We conceptualized 5 key strategies that might help serve as a framework to support mental health programming as part of PEPFAR's current 5-year strategic plan. PEPFAR and the global community have an opportunity to identify mental health service gaps and interweave global mental health priorities with actions to end the HIV and TB epidemics by 2030.

Progress towards the UNAIDS 95-95-95 targets in the Fifth Botswana AIDS Impact Survey (BAIS V 2021): a nationally representative survey

In 2014, UNAIDS set a goal to end the AIDS epidemic by achieving targets for the percentage of people living with HIV who were aware of their status, on antiretroviral therapy (ART), and virally suppressed. In 2020, these targets were revised to 95% for each measure (known as 95-95-95), to be reached among people living with HIV by 2025. We used data from the Fifth Botswana AIDS Impact Survey (BAIS V) to measure progress towards these testing and treatment targets in Botswana. BAIS V used a two-stage cluster design to obtain a nationally representative sample of people aged 15-64 years in Botswana. During March-August, 2021, 14 763 consenting participants were interviewed and tested for HIV in their households by survey teams. HIV-positive specimens were tested for viral load, presence of antiretroviral drugs, and recency of infection using the HIV-1 limiting antigen avidity enzyme immunoassay. Estimates of HIV-positive status and use of ART were based on self-report and the analysis of blood specimens for antiretroviral drugs. Viral load suppression was defined as an HIV RNA concentration of less than 1000 copies per mL. HIV incidence was calculated using the recent infection testing algorithm. Data were weighted to account for the complex survey design. The national HIV prevalence in Botswana among people aged 15-64 years was 20·8% and the annual incidence of HIV infection was 0·2%. 95·1% (men 93·0%, women 96·4%) of people living with HIV aged 15-64 years were aware of their status, 98·0% (men 97·2%, women 98·4%) of those aware were on ART, and 97·9% (men 96·6%, women 98·6%) of those on ART had viral load suppression. Among young people (aged 15-24 years) living with HIV, 84·5% were aware of their status, 98·5% of those aware were on ART, and 91·6% of those on ART had viral load suppression. The prevalance of viral load suppression among all people living with HIV was 91·8%, and varied by district-ranging from 85·3% in Gaborone to 100·0% in Selibe Phikwe. BAIS V is the first population-based survey worldwide to report the achievement of the UNAIDS 95-95-95 goals, both overall and among women. Strategies to reach undiagnosed men and young people, including young women, are needed. US President's Emergency Plan for AIDS Relief.

Evaluation of the impact of PEPFAR transition on retention in care in South Africa's Western Cape Province.

Research on the impact of the US President's Emergency Plan for AIDS Relief (PEPFAR) transition in South Africa (SA) in 2012 found varying results in retention in care (RIC) of people living with HIV (PLWH). To investigate the factors that impacted RIC during the PEPFAR transition in Western Cape Province, SA, in 2012. We used aggregate data from 61 facilities supported by four non-governmental organisations from 2007 to 2015. The main outcome was RIC 12 months after antiretroviral therapy initiation for two periods - during PEPFAR and post PEPFAR. We used adjusted quantile regression to estimate the effect of the PEPFAR pull-out on RIC. Regression models (50th quantile) for 12-month RIC showed a 4.0% (95% CI -7.7 - -0.4%) decline in RIC post-direct service. Facilities supported by Anova/Kheth'impilo fared worst post PEFPAR, with a decline in RIC of -4.9% (95% CI -8.8 - -1.0%), while TB, HIV/AIDS, Treatment Support, and Integrated Therapy (that'sit) fared best (3.6% increase in RIC; 95% CI: -0.2 - 7.3%). There was a decrease in RIC when comparing urban with rural areas (-7.8%; 95% CI -12.8 - -2.9%). City of Cape Town combined with Western Cape Government health facilities showed a substantial decrease (-6.1%; 95% CI -10.6 - -1.7%), while community health clinic (v. central day clinics) declined (-6.4; 95% CI -10.6 - -2.1%) in RIC. We observed no RIC difference by facility size and a slight increase when two or more human resources transitioned from PEPFAR to the government. When PEPFAR funding decreased in 2012, there was a decrease in RIC. To ensure the continuity of HIV care when a major funder withdraws sufficient and stable transition resources, investment in organisations that understand the local context, joint planning and co-ordination are required.

Demographics of sources of HIV-1 transmission in Zambia: a molecular epidemiology analysis in the HPTN 071 PopART study

In the last decade, universally available antiretroviral therapy (ART) has led to greatly improved health and survival of people living with HIV in sub-Saharan Africa, but new infections continue to appear. The design of effective prevention strategies requires the demographic characterisation of individuals acting as sources of infection, which is the aim of this study. Between 2014 and 2018, the HPTN 071 PopART study was conducted to quantify the public health benefits of ART. Viral samples from 7124 study participants in Zambia were deep-sequenced as part of HPTN 071-02 PopART Phylogenetics, an ancillary study. We used these sequences to identify likely transmission pairs. After demographic weighting of the recipients in these pairs to match the overall HIV-positive population, we analysed the demographic characteristics of the sources to better understand transmission in the general population. We identified a total of 300 likely transmission pairs. 178 (59·4%) were male to female, with 130 (95% CI 110-150; 43·3%) from males aged 25-40 years. Overall, men transmitted 2·09-fold (2·06-2·29) more infections per capita than women, a ratio peaking at 5·87 (2·78-15·8) in the 35-39 years source age group. 40 (26-57; 13·2%) transmissions linked individuals from different communities in the trial. Of 288 sources with recorded information on drug resistance mutations, 52 (38-69; 18·1%) carried viruses resistant to first-line ART. HIV-1 transmission in the HPTN 071 study communities comes from a wide range of age and sex groups, and there is no outsized contribution to new infections from importation or drug resistance mutations. Men aged 25-39 years, underserved by current treatment and prevention services, should be prioritised for HIV testing andART. National Institute of Allergy and Infectious Diseases, US President's Emergency Plan for AIDS Relief, International Initiative for Impact Evaluation, Bill & Melinda Gates Foundation, National Institute on Drug Abuse, and National Institute of Mental Health.

Cervical Cancer Screening Positivity Among Women Living With HIV in CDC-PEPFAR Programs 2018-2022.

The US President's Emergency Plan for AIDS Relief aims to address the higher risk of cervical cancer among women living with HIV by offering high-quality screening services in the highest burden regions of the world. We analyzed the US President's Emergency Plan for AIDS Relief Monitoring, Evaluation, and Reporting data from Centers for Disease Control and Prevention-supported sites in 13 countries in sub-Saharan Africa for women living with HIV aged older than 15 years who accessed cervical cancer screening services (mostly visual inspection, with ablative or excisional treatment offered for precancerous lesions), April 2018-March 2022. We calculated the positivity by age, country, and clinical visit type (first lifetime screen or routine rescreening). We fitted negative binomial random coefficient models of log-linear trends in time to estimate the probabilities of testing positive and any temporal trends in positivity. Among the 2.8 million completed cancer screens, 5.4% identified precancerous lesions, and 0.8% were positive for suspected invasive cervical cancers (6.1% overall). The positivity rates declined over the study period among those women screening for cervical cancer for the first time and among those women presenting to antiretroviral therapy clinics for routine rescreening. These positivity rates are lower than expectations set by the published literature. Further research is needed to determine whether these lower rates are attributable to the high level of consistent antiretroviral therapy use among these populations, and systematic program monitoring and quality assurance activities are essential to ensure women living with HIV have access to the highest possible quality prevention services.

Quantifying missed opportunities for tuberculosis among people with HIV in the US President's Emergency Plan for AIDS Relief.

Quantifying missed opportunities for tuberculosis among people with HIV in the US President's Emergency Plan for AIDS Relief.

Trends in HIV prevalence, incidence, and progress towards the UNAIDS 95-95-95 targets in Malawi among individuals aged 15–64 years: population-based HIV impact assessments, 2015−16 and 2020−21

In 2014, UNAIDS set the goal of ending the AIDS epidemic by 2030 through the achievement of testing and treatment cascade targets. To evaluate progress achieved and highlight persisting gaps in HIV epidemic control in Malawi, we aimed to compare key indicators (prevalence, incidence, viral load suppression, and UNAIDS 95-95-95 targets) from the 2015-16 and 2020-21 Malawi Population-based HIV Impact Assessment (PHIA) survey results. The Malawi PHIAs were nationally representative, cross-sectional surveys with a two-stage cluster sampling design. The first survey was conducted between Nov 27, 2015, and Aug 26, 2016; the second survey was conducted between Jan 15, 2020, and April 26, 2021. Our analysis included survey participants aged 15-64 years. Participants were interviewed and a 14 mL blood sample was collected and tested for HIV infection using the national rapid testing algorithm. For each survey, we estimated key HIV epidemic indicators and achievement of 95-95-95 targets. The risk ratio (RR) of the indicators between surveys were computed and considered significant at a confidence level of 0·05. All results were weighted, and self-reported awareness and treatment status were adjusted to account for detection of antiretrovirals. Our analysis included 17 187 participants aged 15-64 years in 2015-16 and 21 208 in 2020-21 who participated in the surveys and blood draw. In the 2020-21 survey, 88·4% (95% CI 86·7-90·0) of people living with HIV were aware of their HIV-positive status; of those aware, 97·8% (97·1-98·5) were on antiretroviral therapy; and of those on treatment, 96·9% (95·9-97·7) were virally suppressed. Between surveys, the national HIV prevalence decreased significantly from 10·6% (10·0-11·2) to 8·9% (8·4-9·5) with RR 0·85 (95% CI 0·78-0·92; p<0·0001). The annual HIV incidence decreased from 0·37% (0·20-0·53) to 0·22% (0·11-0·34) with RR 0·61 (95% CI 0·31-1·20; p=0·15). The population viral load suppression increased from 68·3% (66·0-70·7) in 2015-16 to 87·0% (85·3-88·5) in 2020-21 (RR 1·27 [95% CI 1·22-1·32]; p<0·0001). These results suggest that Malawi had already surpassed the UNAIDS viral load suppression target for 2030 (85·7%) by 2020-21. Through strategies and evidence-informed interventions implemented in the last half decade, especially scale-up of effective HIV treatment, Malawi has made tremendous progress, including decreasing HIV prevalence and incidence and achieving both the second and third 95 targets ahead of 2030. To address the first 95, efforts in HIV diagnosis should focus on males and younger age groups. There is a continued need for effective linkage to care, retention on antiretroviral therapy, and adherence support to maintain and build on progress. US President's Emergency Plan for AIDS Relief through the US Centers for Disease Control and Prevention.

Temporal trends in, and risk factors for, HIV seroconversion among female sex workers accessing Zimbabwe's national sex worker programme, 2009–19: a retrospective cohort analysis of routinely collected HIV testing data

The frequency of new HIV infections among female sex workers in sub-Saharan Africa is poorly understood. We used routinely collected data that enable unique identification of repeat HIV testers to assess temporal trends in seroconversion and identify associated risk factors for female sex workers accessing Sisters with a Voice, Zimbabwe's national sex worker programme. We pooled HIV testing data gathered between Sept 15, 2009, and Dec 31, 2019, from 36 Sisters programme sites in Zimbabwe. We included female sex workers aged 16 years or older with an HIV-negative test and at least one subsequent programme test. We calculated HIV seroconversion rates (using the midpoint between the HIV-positive test and the last negative test as the seroconversion date) and estimated rate ratios to compare 2-year periods by using Poisson regression, with robust SEs to account for clustering by site and adjusting for age and testing frequency to assess temporal trends. We did sensitivity analyses to explore assumptions about seroconversion dates and the effects of variation in follow-up time on our conclusions. Our analysis included data for 6665 female sex workers, 441 (7%) of whom seroconverted. The overall seroconversion rate was 3·8 (95% CI 3·4-4·2) per 100 person-years at risk. Seroconversion rates fell with time since first negative HIV test. After adjustment, there was evidence of a decrease in seroconversion rates from 2009 to 2019 (p=0·0053). In adjusted analyses, being younger than 25 years, and having a sexually transmitted infection diagnosis at a previous visit, were significantly associated with increased seroconversion rates. Our findings were mostly robust to sensitivity analyses, but when 1 month before an HIV-positive test was used as the seroconversion date, seroconversion rates no longer fell with time. We identified high rates of seroconversion shortly after linkage to programme services, which emphasises the need to strengthen HIV prevention programmes from first contact with female sex workers in Zimbabwe. New infections among female sex workers remain challenging to measure, but longitudinal analysis of routine testing data can provide valuable insights into seroconversion rates and associated risk factors. UN Population Fund, Deutsche Gesellschaft für Internationale Zusammenarbeit, the Bill & Melinda Gates Foundation, The Global Fund to Fight AIDS, Tuberculosis and Malaria, US President's Emergency Plan for AIDS Relief, US Agency for International Development, and the Elton John AIDS Foundation.

HIV infection and engagement in the care continuum among migrants and refugees from Venezuela in Colombia: a cross-sectional, biobehavioural survey

Venezuela has experienced substantial human displacement since 2015. To inform HIV programmes and treatment distribution, we aimed to estimate HIV prevalence and associated indicators among migrants and refugees from Venezuela residing in Colombia, the largest receiving country. We conducted a biobehavioural, cross-sectional survey using respondent-driven sampling among Venezuelan people aged 18 years or older who had arrived in Colombia since 2015 and resided in four cities (ie, Bogotá, Soacha, Soledad, and Barranquilla). Participants completed sociobehavioural questionnaires and rapid HIV and syphilis screening with laboratory-based confirmatory testing, CD4 cell counts, and viral load quantification. Policies related to migration status affect access to insurance and HIV services in Colombia, as in many receiving countries, so we provided legal assistance and navigation support to participants with HIV for sustained access to treatment. Population-based estimates were weighted for the complex sampling design. Penalised multivariable logistic regression analysis was used to identify correlates of viral suppression (HIV-1 RNA <1000 copies per mL). Between July 30, 2021, and Feb 5, 2022, 6506 participants were recruited through respondent-driven sampling, of whom 6221 were enrolled. 4046 (65·1%) of 6217 were cisgender women, 2124 (34·2%) of 6217 were cisgender men, and 47 (0·8%) of 6217 were transgender or non-binary people. 71 (1·1%) of all 6221 participants had laboratory-confirmed HIV infection, resulting in a weighted population HIV prevalence of 0·9% (95% CI 0·6-1·4). Among participants living with HIV, 34 (47·9%) of 71 had been previously diagnosed with HIV and 25 (35·7%) of 70 had viral suppression. Individuals with irregular migration status compared with individuals with regular migration status (adjusted odds ratio 0·3, 95% CI 0·1-0·9) and with a most recent HIV test in Colombia compared with a most recent test in Venezuela (0·2, 0·1-0·8) were less likely to have suppressed viral loads. HIV prevalence among migrants and refugees from Venezuela in Colombia suggests the HIV epidemic is close to being generalised, which could be addressed by the inclusion of migrants and refugees from Venezuela in local HIV services, improved access to and navigation support for HIV testing and care, and coordination with humanitarian programmes. There is an association between migration status and viral suppression, conferring both clinical and epidemiological implications. Therefore, legal support and access to insurance might lead to early detection of HIV and timely treatment for people with irregular migration status. US President's Emergency Plan for AIDS Relief through the US Centers for Disease Control and Prevention. For the Spanish translation of the abstract see Supplementary Materials section.

Impact of weight gain with dolutegravir on antiretroviral adherence and viral suppression in four African countries.

We hypothesized that total body weight (TBW) gain after switching antiretroviral therapy (ART) regimen to tenofovir disoproxil fumarate/lamivudine/dolutegravir (TLD) may negatively impact ART adherence and viral load (VL) and therefore sought to examine these associations. The ongoing African Cohort Study (AFRICOS) enrols people with HIV at 12 facilities in Kenya, Nigeria, Tanzania and Uganda supported by The US President's Emergency Plan for AIDS Relief. Among ART-experienced participants who switched to TLD, we used multivariable multinomial logistic regression to examine associations between pre-/post-TLD changes in percentage TBW (≥5% gain, <5% change, ≥5% loss) and changes in self-reported ART adherence (0, 1-2, ≥3 days missed doses in past 30 days) and VL [(<50 copies/mL (undetectable), 50-999 copies/mL (detectable, but suppressed), ≥1000 copies/mL (unsuppressed)]. Among 1508 participants, median time from starting TLD to follow-up was 9 months (interquartile range: 7-11). Overall, 438 (29.1%) participants experienced a TBW gain ≥5%, which was more common among females than among males (32.2% vs 25.2%, p = 0.005) and participants switching from efavirenz [32.0% vs nevirapine (19.9%) and boosted protease inhibitor (20.0%); p < 0.001]. Compared with a TBW change <5% [950 (63.0%) participants], TBW gain ≥5% was not significantly associated with more days with missed ART doses [adjusted odds ratio (aOR) = 0.77, 95% confidence interval (CI): 0.48-1.23] or VL becoming detectable and/or unsuppressed (aOR = 0.69, 95% CI: 0.41-1.16). Although a substantial proportion of participants experienced weight gain after switching to TLD, we did not identify a significant impact on adherence or virological outcomes.

The Status of Adolescent Testing and Treatment in PEPFAR-Supported Programs, October 2017 to September 2020.

Adolescents have poorer outcomes across the HIV cascade compared with adults. We aimed to assess progress in HIV case finding, antiretroviral treatment (ART), viral load coverage (VLC), and viral load suppression (VLS) among adolescents enrolled in the US President's Emergency Plan for AIDS Relief (PEPFAR)-supported programs over a 3-year period that included the beginning of the COVID-19 pandemic. We analyzed PEPFAR program data in 28 countries/regions for adolescents aged 10-19 years between year 1 (October 2017to September 2018), year 2 (October 2018 to September 2019), and year 3 (October 2019 to September 2020). We calculated the number and percent change for HIV tests, HIV-positive tests, and total number on ART. Calculated indicators included positivity, percent of positives newly initiated on ART (ART linkage), VLC (percent of ART patients on ART for ≥6 months with a documented viral load result within the past 12 months), and VLS (percent of viral load tests with <1000 copies/mL). Between years 1 and 3, the number of HIV tests conducted decreased by 44.2%, with a 29.1% decrease in the number of positive tests. Positivity increased from 1.3%-1.6%. The number of adolescents receiving ART increased by 10.4%. In addition, ART linkage increased (77.8%-86.7%) as did VLC (69.4%-79.4%) and VLS (72.8%-81.5%). Our findings demonstrate PEPFAR's success in increasing the adolescent treatment cohort. We identified ongoing gaps in adolescent case finding, linkage, VLC, and VLS that could be addressed with a strategic mix of testing strategies, optimal ART regimens, and adolescent-focused service delivery models.

The HIV care continuum for sexually active transgender women in three metropolitan municipalities in South Africa: findings from a biobehavioural survey 2018–19

Despite high HIV prevalence in transgender women in sub-Saharan Africa, to our knowledge no study presents data across the HIV care continuum for this population in the region. The aim of this study was to estimate HIV prevalence and present data to develop the HIV care continuum indicators for transgender women in three South African metropolitan municipalities. Biobehavioural survey data were collected among sexually active transgender women in the metropolitan municipalities of Johannesburg, Buffalo City, and Cape Town, South Africa. Transgender women (aged ≥18 years, self-reporting consensual sex with a man in the 6 months before the survey) were recruited using respondent-driven sampling (RDS). An interviewer-administered questionnaire was used to determine awareness of HIV status; blood specimens were collected on dried blood spots to test for HIV antibodies, antiretroviral treatment (ART) exposure, and viral load suppression. Population-based estimates of HIV 95-95-95 cascade indicators were derived by use of individualised RDS weights with RDS Analyst software. Multivariate stepwise backward logistic regression modelling was used to determine factors associated with each cascade indicator. All eligible participants were included in the final analysis. Between July 26, 2018, and March 15, 2019, we enrolled 887 sexually active transgender women: 323 in Johannesburg, 305 in Buffalo City, and 259 in Cape Town. HIV prevalence was highest in Johannesburg where 229 (74·1%) of 309 tests were positive (weighted prevalence estimate 63·3%, 95% CI 55·5-70·5), followed by Buffalo City where 121 (43·7%) of 277 were positive (46·1%, 38·7-53·6), and then Cape Town where 122 (48·4%) of 252 were positive (45·6%, 36·7-54·7). In Johannesburg, an estimated 54·2% (95% CI 45·8-62·4) of transgender women with HIV knew their positive status, in Cape Town this was 24·2% (15·4-35·8), and in Buffalo City this was 39·5% (27·1-53·4). Among those who knew their status, 82·1% (73·3-88·5) in Johannesburg, 78·2% (57·9-90·3) in Cape Town, and 64·7% (45·2-80·2) in Buffalo City were on ART. Of those on ART, 34·4% (27·2-42·4) in Johannesburg, 41·2% (30·7-52·6) in Cape Town, and 55·0% (40·7-68·4) in Buffalo City were virally suppressed. Innovative strategies are needed to inform efforts to diagnose and to treat transgender women living with HIV promptly to achieve viral load suppression. Differentiated HIV services tailored to transgender women of race groups other than Black South African, and those with low education attainment and low outreach exposure, innovative testing, and adherence strategies should be developed to improve the HIV cascade for South African transgender women. The US President's Emergency Plan For AIDS Relief and US Centers for Disease Control and Prevention.

Considerations to Improve Pediatric HIV Testing and Close the Treatment Gap in 16 African Countries.

In 2019, South Africa, Nigeria, Tanzania, Democratic Republic of Congo, Uganda, Mozambique, Zambia, Angola, Cameroon, Zimbabwe, Ghana, Ethiopia, Malawi, Kenya, South Sudan and Côte d'Ivoire accounted for 80% of children living with HIV (CLHIV) not receiving HIV treatment. This manuscript describes pediatric HIV testing to inform case-finding strategies. We analyzed US President's Emergency Plan for AIDS Relief monitoring, evaluation, and reporting data (October 1, 2018 to September 30, 2019) for these 16 countries. Number of HIV tests and positive results were reported by age band, country, treatment coverage and testing modality. The number needed to test (NNT) to identify 1 new CLHIV 1-14 years was measured by testing modality and country. The pediatric testing gap was estimated by multiplying the estimated number of CLHIV unaware of their status by NNT per country. Among children, 6,961,225 HIV tests were conducted, and 101,762 CLHIV were identified (NNT 68), meeting 17.6% of the pediatric testing need. Index testing accounted for 13.0% of HIV tests (29.7% of positive results, NNT 30), provider-initiated testing and counseling 65.9% of tests (43.6% of positives, NNT 103), and universal testing at sick entry points 5.3% of tests (6.5% of positives, NNT 58). As countries near HIV epidemic control for adults, the need to increase pediatric testing continues. Each testing modality - PITC, universal testing at sick entry points, and index testing - offers unique benefits. These results illustrate the comparative advantages of including a strategic mix of testing modalities in national programs to increase pediatric HIV case finding.

Impact of universal testing and treatment on sexual risk behaviour and herpes simplex virus type 2: a prespecified secondary outcomes analysis of the HPTN 071 (PopART) community-randomised trial

Comprehensive HIV prevention strategies have raised concerns that knowledge of interventions to reduce risk of HIV infection might mitigate an individual's perception of risk, resulting in riskier sexual behaviour. We investigated the prespecified secondary outcomes of the HPTN 071 (PopART) trial to determine whether a combination HIV prevention strategy, including universal HIV testing and treatment, changed sexual behaviour; specifically, we investigated whether there was evidence of sexual risk compensation. HPTN 071 (PopART) was a cluster-randomised trial conducted during 2013-18, in which we randomly assigned 21 communities with high HIV prevalence in Zambia and South Africa (total population, approximately 1 million) to combination prevention intervention with universal antiretroviral therapy (ART; arm A), prevention intervention with ART provided according to local guidelines (universal since 2016; arm B), or standard of care (arm C). The trial included a population cohort of approximately 2000 randomly selected adults (aged 18-44 years) in each community (N=38 474 at baseline) who were followed up for 36 months. A prespecified secondary objective was to evaluate the impact of the PopART intervention compared with standard of care on herpes simplex virus type 2 (HSV-2) and sexual behaviour (N=20 422 completed final visit). Secondary endpoints included differences in sexual risk behaviour measures at 36 months and were assessed using a two-stage method for matched cluster-randomised trials. This trial is registered with ClinicalTrials. gov, number NCT01900977. The PopART intervention did not substantially change probability of self-reported multiple sex partners, sexual debut, or pregnancy in women at 36 months. Adjusted for baseline community prevalence, reported condomless sex was significantly lower in arm A versus arm C (adjusted prevalence ratio 0·80 [95% CI 0·64-0·99]; p=0·04) but not in arm B versus arm C (0·94 [0·76-1·17]; p=0·55). 3-year HSV-2 incidence was reduced in arm B versus arm C (adjusted risk ratio 0·76 [95% CI 0·63-0·92]; p=0·010); no significant change was shown between arm A versus arm C (0·89 [0·73-1·08]; p=0·199). We found little evidence of any change in sexual behaviour owing to the PopART interventions, and reassuringly for public health, we saw no evidence of sexual risk compensation. The findings do not help to explain the differences between the two intervention groups of the HPTN 071 (PopART) trial. National Institute of Allergy and Infectious Diseases, the National Institutes of Health, the International Initiative for Impact Evaluation (3ie), the Bill &amp; Melinda Gates Foundation, the US President's Emergency Plan for AIDS Relief, and the Medical Research Council UK.

Projected outcomes of universal testing and treatment in a generalised HIV epidemic in Zambia and South Africa (the HPTN 071 [PopART] trial): a modelling study

The long-term impact of universal home-based testing and treatment as part of universal testing and treatment (UTT) on HIV incidence is unknown. We made projections using a detailed individual-based model of the effect of the intervention delivered in the HPTN 071 (PopART) cluster-randomised trial. In this modelling study, we fitted an individual-based model to the HIV epidemic and HIV care cascade in 21 high prevalence communities in Zambia and South Africa that were part of the PopART cluster-randomised trial (intervention period Nov 1, 2013, to Dec 31, 2017). The model represents coverage of home-based testing and counselling by age and sex, delivered as part of the trial, antiretroviral therapy (ART) uptake, and any changes in national guidelines on ART eligibility. In PopART, communities were randomly assigned to one of three arms: arm A received the full PopART intervention for all individuals who tested positive for HIV, arm B received the intervention with ART provided in accordance with national guidelines, and arm C received standard of care. We fitted the model to trial data twice using Approximate Bayesian Computation, once before data unblinding and then again after data unblinding. We compared projections of intervention impact with observed effects, and for four different scenarios of UTT up to Jan 1, 2030 in the study communities. Compared with standard of care, a 51% (95% credible interval 40-60) reduction in HIV incidence is projected if the trial intervention (arms A and B combined) is continued from 2020 to 2030, over and above a declining trend in HIV incidence under standard of care. A widespread and continued commitment to UTT via home-based testing and counselling can have a substantial effect on HIV incidence in high prevalence communities. National Institute of Allergy and Infectious Diseases, US President's Emergency Plan for AIDS Relief, International Initiative for Impact Evaluation, Bill &amp; Melinda Gates Foundation, National Institute on Drug Abuse, and National Institute of Mental Health.

Viral suppression and self-reported ART adherence after 3 years of universal testing and treatment in the HPTN 071 (PopART) community-randomised trial in Zambia and South Africa: a cross-sectional analysis

In 2014, UNAIDS set the target that 90% of individuals on antiretroviral therapy (ART) be virally suppressed. Here, we use data from the HPTN 071 (PopART) trial to report whether the introduction of universal testing and treatment has affected viral suppression or treatment adherence among individuals who self-reported they were taking ART, and identify risk factors for these outcomes. This was a cross-sectional study nested within the randomly selected population cohort of the PopART trial. The trial took place in 21 communities in Zambia and South Africa. Analyses included 3570 HIV-positive participants who were seen at the second follow-up visit in 2016-17 and who self-reported that they were currently taking ART. Viral suppression was defined as HIV RNA of less than 400 copies per mL from a blood sample collected during the cohort visit, and ART adherence was measured using self-reporting (reported as no missed pills in last 7 days). Prevalences of these outcomes were compared across three trial arms using a two-stage approach suitable for clustered data. Each arm consisted of seven communities, with one arm receiving a combination HIV prevention package including immediate ART initiation, one receiving a combination HIV prevention package excluding immediate ART initiation and one arm receving standard of care. Risk factors for each of the outcomes were assessed using logistic regression. Among the 3570 participants who self-reported that they were currently on ART, 416 (11·7%) of 3554 were not virally suppressed (16 were missing viral suppression status) and 345 (9·7%) of 3566 reported being non-adherent to ART (four were missing adherence status). The proportion not virally suppressed was higher in communities in South Africa (195 [16·4%] of 1191) than in Zambia (221 [9·4%] of 2363). There was no evidence that the prevalence of the outcomes differed between trial arms. There was evidence that men, younger individuals, individuals who reported participating in harmful alcohol use, and those who reported internalised stigma were more likely to be non-adherent, and not virally suppressed. The results assuaged concerns that early ART initiation in a universal testing and treatment setting could lead to reduced adherence and viral suppression. US National Institute of Allergy and Infectious Diseases (which is a part of the National Institutes of Health), the International Initiative for Impact Evaluation with support from the Bill &amp; Melinda Gates Foundation, US President's Emergency Plan for AIDS Relief, and Medical Research Council UK.

Initial implementation of HIV pre-exposure prophylaxis for people who are incarcerated in Zambia: a cross-sectional observational study

There are over 23 000 incarcerated people in Zambia, a population which has higher HIV prevalence than the general population yet has no access to HIV prevention. To evaluate the feasibility of HIV pre-exposure prophylaxis (PrEP) implementation in Zambian criminal justice facilities, we offered PrEP services to incarcerated people and aimed to describe early implementation outcomes. In this cross-sectional observational study, we implemented a PrEP programme between Oct 1, 2020, and March 31, 2021, supporting 16 criminal justice facilities in four Zambian provinces. Before implementation, we held stakeholder engagement meetings with Zambia Correctional Service officials to discuss PrEP benefits, and trained Zambia Correctional Service health-care workers in PrEP management using the national PrEP training package. People who were incarcerated and screened positive for substantial HIV risk by use of a standardised HIV risk assessment tool were offered voluntary HIV testing and counselling. Those who tested positive were linked to antiretroviral therapy, and those who tested negative and met national HIV prevention eligibility criteria were offered PrEP. We assessed PrEP uptake and used descriptive statistics to characterise programme beneficiaries and the cascade of PrEP services. During the study period, we reached 12 367 people older than 15 years with HIV risk assessment and counselling, including 11 794 (95·4%) men and 573 (4·6%) women. Of these, 2610 people received HIV testing, with 357 (13·7%) testing HIV positive; positivity was significantly higher in women (20·6%) than men (13·2%, p=0·011). 1276 people were identified as HIV negative and PrEP eligible. Of these, 1190 (93·3%) initiated PrEP. The age group with the highest proportion reached and initiated on PrEP was those aged 25-29 years, representing 19·2% (2377 of 12 367) of all people reached and 24·1% (287 of 1190) of those who initiated PrEP. Delivery of PrEP to people who are incarcerated is feasible with adequate resourcing and support to the criminal justice health system, and can result in high uptake among eligible individuals. Further assessment is needed of PrEP persistence and adherence, and the perceptions of people who are incarcerated regarding their HIV risk and preferences for combination HIV prevention services. US President's Emergency Plan for AIDS Relief through the US Centers for Disease Control and Prevention.

Effects of COVID-19 Pandemic on Voluntary Medical Male Circumcision Services for HIV Prevention, Sub-Saharan Africa, 2020.

Beginning in March 2020, to reduce COVID-19 transmission, the US President's Emergency Plan for AIDS Relief supporting voluntary medical male circumcision (VMMC) services was delayed in 15 sub-Saharan African countries. We reviewed performance indicators to compare the number of VMMCs performed in 2020 with those performed in previous years. In all countries, the annual number of VMMCs performed decreased 32.5% (from 3,898,960 in 2019 to 2,631,951 in 2020). That reduction is largely attributed to national and local COVID-19 mitigation measures instituted by ministries of health. Overall, 66.7% of the VMMC global annual target was met in 2020, compared with 102.0% in 2019. Countries were not uniformly affected; South Africa achieved only 30.7% of its annual target in 2020, but Rwanda achieved 123.0%. Continued disruption to the VMMC program may lead to reduced circumcision coverage and potentially increased HIV-susceptible populations. Strategies for modifying VMMC services provide lessons for adapting healthcare systems during a global pandemic.

Leveraging PEPFAR-Supported Health Information Systems for COVID-19 Pandemic Response.

Since 2003, the US President's Emergency Plan for AIDS Relief (PEPFAR) has supported implementation and maintenance of health information systems for HIV/AIDS and related diseases, such as tuberculosis, in numerous countries. As the COVID-19 pandemic emerged, several countries conducted rapid assessments and enhanced existing PEPFAR-funded HIV and national health information systems to support COVID-19 surveillance data collection, analysis, visualization, and reporting needs. We describe efforts at the US Centers for Disease Control and Prevention (CDC) headquarters in Atlanta, Georgia, USA, and CDC country offices that enhanced existing health information systems in support COVID-19 pandemic response. We describe CDC activities in Haiti as an illustration of efforts in PEPFAR countries. We also describe how investments used to establish and maintain standards-based health information systems in resource-constrained settings can have positive effects on health systems beyond their original scope.

Contribution of PEPFAR-Supported HIV and TB Molecular Diagnostic Networks to COVID-19 Testing Preparedness in 16 Countries.

The US President's Emergency Plan for AIDS Relief (PEPFAR) supports molecular HIV and tuberculosis diagnostic networks and information management systems in low- and middle-income countries. We describe how national programs leveraged these PEPFAR-supported laboratory resources for SARS-CoV-2 testing during the COVID-19 pandemic. We sent a spreadsheet template consisting of 46 indicators for assessing the use of PEPFAR-supported diagnostic networks for COVID-19 pandemic response activities during April 1, 2020, to March 31, 2021, to 27 PEPFAR-supported countries or regions. A total of 109 PEPFAR-supported centralized HIV viral load and early infant diagnosis laboratories and 138 decentralized HIV and TB sites reported performing SARS-CoV-2 testing in 16 countries. Together, these sites contributed to >3.4 million SARS-CoV-2 tests during the 1-year period. Our findings illustrate that PEPFAR-supported diagnostic networks provided a wide range of resources to respond to emergency COVID-19 diagnostic testing in 16 low- and middle-income countries.