Pre-Exposure Prophylaxis (PrEP) is recommended as an HIV prevention measure for men who have sex with men (MSM). We assessed factors associated with PrEP retention and adherence among MSM in Kigali, Rwanda. We undertook a retrospective cross-sectional study and used a questionnaire to obtain PrEP retention and adherence history from MSM enrolled in the key population (KP) program that attended scheduled follow-up clinics from four (4) health facilities between April 2021 to June 2021. Retention was defined as attending scheduled PrEP follow-up appointments and adherence as taking PrEP medication 95% or more of the time. We used multivariable cox proportion hazard regression to determine factors associated with 3-month retention and principal component analysis (PCA) to determine factors associated with self-reported adherence. Data were analyzed using STATA (version 16.0). We interviewed 439 MSM aged 18 years and above that were initiated on PrEP. Majority were employed (57%, n = 251), between ages 25-34 years (49%, n = 217), close to half completed primary level education (47%, n = 206), were involved in sex work (42%, n = 184), and over a half lived in household of 1-2 members (55%, n = 241). Ninety percent of the MSM respondents (n = 393) were retained on PrEP at 3 months and among those retained, 287 (73%) had good adherence. Multivariable cox regression revealed that MSM more likely to be retained on PrEP, were those that are sex workers (adjusted Hazard Ratio (aHR) = 4.139; 95% Confidence Interval (95%CI): 1.569, 10.921), had more than one (1) regular sexual partners (aHR = 3.949; 95%CI: 2.221, 7.022), lived in households of 3-5 members (aHR = 3.755; 95%CI: 1.706, 8.261), completed secondary school education (aHR = 2.154; 95%CI: 1.130, 4.108), and were circumcised (aHR = 2.218, 95%CI: 1.232, 3.993). Employed MSM had a 66% decreased likelihood to be retained on PrEP (aHR = 0.345; 95%CI: 0.168, 0.707). Similarly, MSM that used condoms consistently had an 85% decreased likelihood to be retained on PrEP (aHR = 0.149; 95%CI: 0.035, 0.632). Principal component regression analysis showed that the component with MSM with higher numbers of regular sexual partners had increased odds of adhering to PrEP (Crude Odds Ratio (cOR) = 1.32; 95%CI: 1.144, 1.530). The study highlighted that MSM using PrEP as the main method of HIV prevention were more likely to be retained and adherent to PrEP. There is need to emphasize PrEP use alongside other HIV prevention methods and targeted STI testing and treatment among PrEP users.

BACKGROUND: Scaling-up antiretroviral therapy (ART) in resource-limited settings has raised concerns of emerging HIV drug resistance (DR) and its transmission to newly infected individuals. To assess the prevalence of transmitted drug resistance (TDR) in recently HIV-infected individuals, a WHO TDR threshold survey was conducted among young adults in Kigali, Rwanda. METHODS: Between May and July 2011, HIV subtype and genotyping were performed on dried blood spots (DBS) prepared from blood specimens collected from newly HIV-diagnosed and ART-naive individuals aged 15 to 21 years in eight HIV voluntary counselling and testing (VCT) sites in Kigali. RESULTS: In total, 57 of the 68 DBS collected from eligible participants were successfully amplified. The median age of participants was 20 years and 86% were female. Most participants (96%) were infected with subtype A1 virus. Two participants (4%) had the K103N non-nucleoside reverse transcriptase inhibitor (NNRTI) mutation and one (2%) had the M46L protease inhibitor (PI) mutation. The TDR prevalence was 3.5% (95% CI 0.4, 12.1) for NNRTI and 1.8% (95% CI 0.0, 9.4) for PI. CONCLUSIONS: The prevalence of HIV TDR in VCT attendees in Kigali was characterized as low (<5%) for all drug classes according to the WHO HIV DR threshold survey methodology. Despite a decade of widespread ART in Rwanda, TDR prevalence remains low, and so the current first-line ART regimens should continue to be effective. However, as scale-up of ART continues, frequent HIV DR surveillance is needed to monitor the effectiveness of available ART regimens at the population level.

Identifying persons who have newly acquired HIV infections is critical for characterizing the HIV epidemic direction. We analyzed pooled data from nationally representative Population-Based HIV Impact Assessment surveys conducted across 14 countries in Africa for recent infection risk factors. We included adults 15-49 years of age who had sex during the previous year and used a recent infection testing algorithm to distinguish recent from long-term infections. We collected risk factor information via participant interviews and assessed correlates of recent infection using multinomial logistic regression, incorporating each survey's complex sampling design. Compared with HIV-negative persons, persons with higher odds of recent HIV infection were women, were divorced/separated/widowed, had multiple recent sex partners, had a recent HIV-positive sex partner or one with unknown status, and lived in communities with higher HIV viremia prevalence. Prevention programs focusing on persons at higher risk for HIV and their sexual partners will contribute to reducing HIV incidence.

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.

BACKGROUND: We examined the epidemiology and transmission potential of HIV population viral load (VL) in 12 sub-Saharan African countries. METHODS: We analyzed data from Population-based HIV Impact Assessments (PHIAs), large national household-based surveys conducted between 2015 and 2019 in Cameroon, Cote d'Ivoire, Eswatini, Kenya, Lesotho, Malawi, Namibia, Rwanda, Tanzania, Uganda, Zambia, and Zimbabwe. Blood-based biomarkers included HIV serology, recency of HIV infection, and VL. We estimated the number of people living with HIV (PLHIV) with suppressed viral load (<1,000 HIV-1 RNA copies/mL) and with unsuppressed viral load (viremic), the prevalence of unsuppressed HIV (population viremia), sex-specific HIV transmission ratios (number female incident HIV-1 infections/number unsuppressed male PLHIV per 100 persons-years [PY] and vice versa) and examined correlations between a variety of VL metrics and incident HIV. Country sample sizes ranged from 10,016 (Eswatini) to 30,637 (Rwanda); estimates were weighted and restricted to participants 15 years and older. RESULTS: The proportion of female PLHIV with viral suppression was higher than that among males in all countries, however, the number of unsuppressed females outnumbered that of unsuppressed males in all countries due to higher overall female HIV prevalence, with ratios ranging from 1.08 to 2.10 (median: 1.43). The spatial distribution of HIV seroprevalence, viremia prevalence, and number of unsuppressed adults often differed substantially within the same countries. The 1% and 5% of PLHIV with the highest VL on average accounted for 34% and 66%, respectively, of countries' total VL. HIV transmission ratios varied widely across countries and were higher for male-to-female (range: 2.3-28.3/100 PY) than for female-to-male transmission (range: 1.5-10.6/100 PY). In all countries mean log10 VL among unsuppressed males was higher than that among females. Correlations between VL measures and incident HIV varied, were weaker for VL metrics among females compared to males and were strongest for the number of unsuppressed PLHIV per 100 HIV-negative adults (R2 = 0.92). CONCLUSIONS: Despite higher proportions of viral suppression, female unsuppressed PLHIV outnumbered males in all countries examined. Unsuppressed male PLHIV have consistently higher VL and a higher risk of transmitting HIV than females. Just 5% of PLHIV account for almost two-thirds of countries' total VL. Population-level VL metrics help monitor the epidemic and highlight key programmatic gaps in these African countries.

In this study, we measured Rwandan men's engagement in HIV services based on the UNAIDS 90-90-90 targets and assessed factors associated with linkage to HIV services. We analyzed the Rwanda Population-based HIV Impact Assessment (RPHIA) data for 15-64-year-old males. We conducted bivariate analysis to assess the distribution and association of sociodemographic characteristics with UNAIDS 90-90-90 targets. We adjusted multi-variable models to understand the effect measurement of associated factors and determine the factors that best predict the achievement of UNAIDS 90-90-90. Of 13,780 males aged 15-64 years who participated in the RPHIA and consented to the blood draw and HIV testing, 302 had a positive HIV result while 301 had valid responses to all variables analyzed in this paper and were included in the analysis. We found that age group was an explanatory and predictive factor for achievement of UNAIDS 90-90-90. Younger men living with HIV (MLHIV) are less likely to have achieved UNAIDS 90-90-90 compared to MLHIV 50-64 years old: aOR for MLHIV aged 15-34 years was 0.21 (0.08, 0.53) and aOR for MLHIV aged 35-49 years was0.77 (0.36, 1.66). To close the UNAIDS 90-90-90 gap in Rwanda, innovative service delivery strategies are needed to support young MLHIV to reach 90-90-90. This article is protected by copyright. All rights reserved.

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.

INTRODUCTION: Achieving optimal HIV outcomes, as measured by global 90-90-90 targets, that is awareness of HIV-positive status, receipt of antiretroviral (ARV) therapy among aware and viral load (VL) suppression among those on ARVs, respectively, is critical. However, few data from sub-Saharan Africa (SSA) are available on older people (50+) living with HIV (OPLWH). We examined 90-90-90 progress by age, 15-49 (as a comparison) and 50+ years, with further analyses among 50+ (55-59, 60-64, 65+ vs. 50-54), in 13 countries (Cameroon, Cote d'Ivoire, Eswatini, Ethiopia, Kenya, Lesotho, Malawi, Namibia, Rwanda, Tanzania, Uganda, Zambia and Zimbabwe). METHODS: Using data from nationally representative Population-based HIV Impact Assessments, conducted between 2015and 2019, participants from randomly selected households provided demographic and clinical information and whole blood specimens for HIV serology, VL and ARV testing. Survey weighted outcomes were estimated for 90-90-90 targets. Country-specific Poisson regression models examined 90-90-90 variation among OPLWH age strata. RESULTS: Analyses included 24,826 HIV-positive individuals (15-49 years: 20,170; 50+ years: 4656). The first, second and third 90 outcomes were achieved in 1, 10 and 5 countries, respectively, by those aged 15-49, while OPLWH achieved outcomes in 3, 13 and 12 countries, respectively. Among those aged 15-49, women were more likely to achieve 90-90-90 targets than men; however, among OPLWH, men were more likely to achieve first and third 90 targets than women, with second 90 achievement being equivalent. Country-specific 90-90-90 regression models among OPLWH demonstrated minimal variation by age stratum across 13 countries. Among OLPWH, no first 90 target differences were noted by age strata; three countries varied in the second 90 by older age strata but not in a consistent direction; one country showed higher achievement of the third 90 in an older age stratum. CONCLUSIONS: While OPLWH in these 13 countries were slightly more likely than younger people to be aware of their HIV-positive status (first 90), this target was not achieved in most countries. However, OPLWH achieved treatment (second 90) and VL suppression (third 90) targets in more countries than PLWH <50. Findings support expanded HIV testing, prevention and treatment services to meet ongoing OPLWH health needs in SSA.

BACKGROUND: We assessed the prevalence of acquired HIV drug resistance (HIVDR) and associated factors among patients receiving first-line antiretroviral therapy (ART) in Rwanda. METHODS: This cross-sectional study included 702 patients receiving first-line ART for at least 6months with last viral load (VL) results 1000 copies/mL. Blood plasma samples were subjected to VL testing; specimens with unsuppressed VL were genotyped to identify HIVDR-associated mutations. Data were analysed using STATA/SE. RESULTS: Median time on ART was 86.4 months (interquartile range [IQR], 44.8-130.2months), and median CD4 count at ART initiation was 311 cells/mm(3) (IQR, 197-484 cells/mm(3)). Of 414 (68.2%) samples with unsuppressed VL, 378 (88.3%) were genotyped. HIVDR included 347 (90.4%) non-nucleoside reverse transcriptase inhibitor- (NNRTI), 291 (75.5%) nucleoside reverse transcriptase inhibitor- (NRTI) and 13 (3.5%) protease inhibitor (PI) resistance-associated mutations. The most common HIVDR mutations were K65R (22.7%), M184V (15.4%) and D67N (9.8%) for NRTIs and K103N (34.4%) and Y181C/I/V/YC (7%) for NNRTIs. Independent predictors of acquired HIVDR included current ART regimen of zidovudine + lamivudine + nevirapine (adjusted odds ratio [aOR], 3.333 [95% confidence interval (CI): 1.022-10.870]; p = 0.046) for NRTI resistance and current ART regimen of tenofovir + emtricitabine + nevirapine (aOR, 0.148 [95% CI: 0.028-0.779]; p = 0.025), zidovudine + lamivudine + efavirenz (aOR, 0.105 [95% CI: 0.016-0.693]; p = 0.020) and zidovudine + lamivudine + nevirapine (aOR, 0.259 [95% CI: 0.084-0.793]; p = 0.019) for NNRTI resistance. History of ever switching ART regimen was associated with NRTI resistance (aOR, 2.53 [95% CI: 1.198-5.356]; p = 0.016) and NNRTI resistance (aOR, 3.23 [95% CI: 1.435-7.278], p = 0.005). CONCLUSION: The prevalence of acquired HIV drug resistance (HIVDR) was high among patient failing to re-suppress VL and was associated with current ART regimen and ever switching ART regimen. The findings of this study support the current WHO guidelines recommending that patients on an NNRTI-based regimen should be switched based on a single viral load test and suggests that national HIV VL monitoring of patients receiving ART has prevented long-term treatment failure that would result in the accumulation of TAMs and potential loss of efficacy of all NRTI used in second-line ART as the backbone in combination with either dolutegravir or boosted PIs.

OBJECTIVES: The 2018-19 Rwanda Population-based HIV Impact Assessment (RPHIA) was conducted to measure national HIV incidence and prevalence. District-level estimates were modeled to inform resources allocation. METHODS: RPHIA was a nationally representative cross-sectional household survey. Consenting adults were interviewed and tested for HIV using the national diagnostic algorithm followed by laboratory-based confirmation of HIV status, and testing for viral load (VL), limiting antigen (LAg) avidity and presence of antiretrovirals. Incidence was calculated using normalized optical density ≤ 1•5, VL ≥ 1,000 copies/mL, and undetectable antiretrovirals. Survey and programmatic data were used to model district-level HIV incidence and prevalence. RESULTS: Of 31,028 eligible adults, 98•7% participated in RPHIA and 934 tested HIV positive. HIV prevalence among adults in Rwanda was 3•0% (95% CI:2•7-3•3). National HIV incidence was 0•08% (95% CI:0•02-0•14) and 0•11% (95% CI:0•00-0•26) in the City of Kigali (CoK). Based on district-level modeling, HIV incidence was greatest in the three CoK districts (0•11% to 0•15%) and varied across other districts (0•03% to 0•10%). CONCLUSIONS: HIV prevalence among adults in Rwanda is 3.0%; HIV incidence is low at 0.08%. District-level modeling has identified disproportionately affected urban hotspots: areas to focus resources.

BACKGROUND: Despite Rwanda's progress toward HIV epidemic control, 16.2% of HIV-positive individuals are unaware of their HIV positive status. Tailoring the public health strategy could help reach these individuals with new HIV infection and achieve epidemic control. Recency testing is primarily for surveillance, monitoring, and evaluation but it's not for diagnostic purposes. However, it's important to know what proportion of the newly diagnosed are recent infections so that HIV prevention can be tailored to the profile of people who are recently infected. We therefore used available national data to characterize individuals with recent HIV infection in Rwanda to inform the epidemic response. METHODS: We included all national-level data for recency testing reported from October 2018 to June 2020. Eligible participants were adults (aged ≥15 years) who had a new HIV diagnosis, who self-reported being antiretroviral therapy (ART) naïve, and who had consented to recency testing. Numbers and proportions of recent HIV infections were estimated, and precision around these estimates was calculated with 95% confidence intervals (CI). Logistic regression was used to assess factors associated with being recently (within 12 months) infected with HIV. RESULTS: Of 7,785 eligible individuals with a new HIV-positive diagnosis, 475 (6.1%) met the criteria for RITA recent infection. The proportion of RITA recent infections among individuals with newly identified HIV was high among those aged 15-24 years (9.6%) and in men aged ≥65 years (10.3%) compared to other age groups; and were higher among women (6.7%) than men (5.1%). Of all recent cases, 68.8% were women, and 72.2% were aged 15-34 years. The Northern province had the fewest individuals with newly diagnosed HIV but had the highest proportion of recent infections (10.0%) compared to other provinces. Recent infections decreased by 19.6% per unit change in time (measured in months). Patients aged ≥25 years were less likely to have recent infection than those aged 15-24 years with those aged 35-49 years being the least likely to have recent infection compared to those aged 15-24 years (adjusted odds ratio [aOR], 0.415 [95% CI: 0.316-0.544]). CONCLUSION: Public health surveillance targeting the areas and the identified groups with high risk of recent infection could help improve outcomes.

Establishing accurate population size estimates (PSE) is important for prioritising and planning provision of services. Multiple source capture-recapture sampling method increases PSE accuracy and reliability. In August 2018, the three-source capture-recapture (3S-CRC) method was employed with a stringent assumption of sample independence to estimate the number of female sex workers (FSW) in Rwanda. Using Rwanda 2017 FSW hotspots mapping data, street and venue-based FSW were sampled at the sector level of each province and tagged with two unique gifts. Each capture was completed within one week to minimise FSW migration between provinces and recall bias. The three captures had 1042, 1204 and 1488 FSW. There were 111 FSW recaptured between captures 1 and 2; 237 between captures 2 and 3; 203 between captures 1 and 3 and 46 captured in all three. The PSE for street and venue-based FSW in Rwanda lies within 95% credible set: 8328-22 806 with corresponding median of 13 716 FSW. The 3S-CRC technique was low-cost and relatively easy to use for PSE in hard-to-reach populations. This estimate provides the basis for determining the denominators to assess HIV programme performance towards FSW and epidemic control and warrants further PSE for home- and cyber-based FSW in Rwanda.

BACKGROUND: In 2012, Rwanda introduced a Treat All approach for HIV-infected children younger than 5 years. We compared antiretroviral therapy (ART) initiation, outcomes, and retention, before and after this change. METHODS: We conducted a retrospective study of children enrolled into care between June 2009 and December 2011 [Before Treat All (BTA) cohort] and between July 2012 and April 2015 [Treat All (TA) cohort]. SETTING: Medical records of a nationally representative sample were abstracted for all eligible aged 18-60 months from 100 Rwandan public health facilities. RESULTS: We abstracted 374 medical records: 227 in the BTA and 147 in the TA cohorts. Mean (SD) age at enrollment was [3 years (1.1)]. Among BTA, 59% initiated ART within 1 year, vs. 89% in the TA cohort. Median time to ART initiation was 68 days (interquartile range 14-494) for BTA and 9 days (interquartile range 0-28) for TA (P < 0.0001), with 9 (5%) undergoing same-day initiation in BTA compared with 50 (37%) in TA (P < 0.0001). Before ART initiation, 59% in the BTA reported at least one health condition compared with 35% in the TA cohort (P < 0.0001). Although overall loss to follow-up was similar between cohorts (BTA: 13%, TA: 8%, P = 0.18), loss to follow-up before ART was significantly higher in the BTA (8%) compared with the TA cohort (2%) (P = 0.02). CONCLUSIONS: Nearly 90% of Rwandan children started on ART within 1 year of enrollment, most within 1 month, with greater than 90% retention after implementation of TA. TA was also associated with fewer morbidities.

Rwanda has made significant progress in expanding pediatric antiretroviral treatment coverage. This was a nationwide, cross-sectional study of pediatric HIV suppression rates. Of 292 children on antiretroviral treatment >/=12 months, 68.8% achieved viral suppression < 40 copies/ml, respectively. Rwanda achieved good pediatric viral suppression rates, comparable to those from other resource-limited settings, yet more efforts are needed to achieve the UNAIDS 90-90-90 target.

BACKGROUND: HIV infection is linked to decreased fertility and fertility desires in sub-Saharan Africa due to biological and social factors. We investigate the relationship between HIV infection and fertility or fertility desires in the context of universal access to antiretroviral therapy introduced in 2004 in Rwanda. METHODS: We used data from 3532 and 4527 women aged 20-49 from the 2005 and 2010 Rwandan Demographic and Health Surveys (RDHS), respectively. The RDHSs included blood-tests for HIV, as well as detailed interviews about fertility, demographic and behavioral outcomes. In both years, multiple logistic regression was used to assess the association between HIV and fertility outcomes within three age categories (20-29, 30-39 and 40-49 years), controlling for confounders and compensating for the complex survey design. RESULTS: In 2010, we did not find a difference in the odds of pregnancy in the last 5 years between HIV-seropositive and HIV-seronegative women after controlling for potential biological and social confounders. Controlling for the same confounders, we found that HIV-seropositive women under age 40 were less likely to desire more children compared to HIV-seronegative women (20-29 years adjusted odds ratio (AOR) = 0.31, 95% CI: 0.17, 0.58; 30-39 years AOR = 0.24, 95% CI: 0.14, 0.43), but no difference was found among women aged 40 or older. No associations between HIV and fertility or fertility desire were found in 2005. CONCLUSIONS: These findings suggest no difference in births or current pregnancy among HIV-seropositive and HIV-seronegative women. That in 2010 HIV-seropositive women in their earlier childbearing years desired fewer children than HIV-seronegative women could suggest more women with HIV survived; and stigma, fear of transmitting HIV, or realism about living with HIV and prematurely dying from HIV may affect their desire to have children. These findings emphasize the importance of delivering appropriate information about pregnancy and childbearing to HIV-infected women, enabling women living with HIV to make informed decisions about their reproductive life.

BACKGROUND: For efficiency and ethical considerations, in 2013 the World Health Organization (WHO) recommended to investigate transitioning from antenatal clinic-based surveillance to the prevention of mother to child transmission- (PMTCT-) based routine data. An assessment on the readiness for this transition was carried out in Rwanda in 2011 and 2013. METHODS: This assessment applied the WHO recommended methods which compares individual HIV rapid testing at site and antenatal surveillance results in all existing 30 sites involving 13,292 women. In addition, PMTCT HIV-testing quality assurance and PMTCT routine data quality were assessed in 27 out of 30 sites. RESULTS: All sentinel sites provided PMTCT services and had a high uptake of HIV testing (more than 90%). In all sites, PMTCT data were recorded in longitudinal and standardized ANC registers. Twenty six out of 27 sites had HIV result completeness above 90%. Positive percent agreement (97.5%) and negative percent agreement (99.9%) were observed between routine PMTCT and sero-surveillance HIV test results. Of 27 sites, 25 scored more than 80% in all phases of HIV testing quality assurance. CONCLUSIONS: According to WHO standards, Rwanda antenatal clinic HIV sero-surveillance is ready to transition to PMTCT-based sero-surveillance.

Agnes Binagwaho and colleagues describe how Rwanda achieved country ownership of its HIV programs.

BACKGROUND: By December 2007, over 48,000 persons had initiated antiretroviral treatment (ART) at 171 clinics in Rwanda. Assessing national ART program outcomes is essential to determine whether programs have the desired impact. METHODS: We conducted a retrospective cohort study to assess key 6- and 12-month outcomes among a nationally representative, stratified, random sample of 3194 adults (> or =15 years) who initiated ART from January 1, 2004, through December 31, 2005. FINDINGS: At ART initiation, the median patient age was 37 years and 65% were female. Overall, the baseline median CD4 cell count was 141 cells per microliter. At 6 and 12 months after ART initiation, 92% and 86% of patients, respectively, remained on ART at their original site. By 6 months, 3.6% were dead and 3.4% were lost to follow-up; by 12 months, 4.6% were dead and 4.9% were lost to follow-up. Among patients with available follow-up CD4 cell count data, median CD4 cell counts increased by 98 cells per microliter and 119 cells per microliter at 6 and 12 months after ART initiation, respectively. CONCLUSIONS: Rwanda's national ART program achieved excellent 6- and 12-month retention and immunologic outcomes during the first 2 years of rapid scale-up. Routine supervision is required to improve compliance with clinical guidelines and data quality.