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.

Tracing-corrected estimates of disengagement from HIV care and mortality among patients enrolling in HIV care without overt immunosuppression in Tanzania.

In the era of "test and treat", it is important to understand HIV care outcomes and their determinants in patients presenting to care with early-stage disease. We surveyed 924 adults newly enrolling in HIV care at four clinics in Tanzania before the adoption of universal treatment eligibility, and collected longitudinal clinical data. Participants who defaulted from care were tracked in the community. Cumulative incidence of disengagement from care and death was estimated using competing risk methods. By 12 months after enrollment, 18.2% of patients had disengaged from care and 6.9% had died. Factors associated with disengagement included male sex (adjusted subhazard ratio [aSHR] versus female = 1.75, 95% confidence interval [CI]: 1.06-2.89), provider-initiated HIV diagnosis (aSHR versus self-referred = 1.71, 95% CI: 1.03-2.86), ineligibility for antiretroviral treatment (ART) at enrollment (aSHR versus eligibility = 2.82, 95% CI: 1.84-4.32) and increased anticipated stigma score (aSHR = 1.04 per 5-point increase, 95% CI: 1.02-1.05). Higher life satisfaction score (aSHR = 0.97 per 5-point increase, 95% CI: 0.95-0.99) and having 1-2 close friends (aSHR versus none = 0.58, 95% CI: 0.47-0.71) were protective. The findings highlight the continued importance of social environment for HIV care outcomes and the potential of universal ART eligibility to reduce HIV care attrition.

Known HIV status among adolescent women attending antenatal care services in Eswatini, Ethiopia and Mozambique.

BACKGROUND: Antenatal care (ANC) clinics remain important entry points to HIV care for pregnant women living with HIV-including adolescents. Prior knowledge of their HIV status at ANC enrollment is crucial to providing services for prevention of mother-to-child transmission (PMTCT) of HIV. We examined known HIV status of pregnant adolescents and women in other age groups at ANC enrollment. METHODS: A descriptive study of routinely reported PMTCT data from 419 facilities in Eswatini, Ethiopia, and Mozambique, from January through December 2018 was conducted. We assessed knowledge of HIV status by country for three age groups: adolescents aged 15-19 years, young women aged 20-24 years, and older women aged 25-49 years. We report HIV prevalence and proportions of known and newly diagnosed HIV infections in women, by age group and country. The data were summarized by frequencies and proportions, including their 95% confidence intervals. RESULTS: Among the facilities examined, 52 (12.4%) were in Eswatini, 63 (15.0%) in Ethiopia, and 304 (72.6%) in Mozambique. Across three countries, 488,121 women attended a first ANC visit and 23,917 (4.9%) were HIV-positive. Adolescents constituted 22% of all ANC attendees, whereas young and older women represented 33% and 45%, respectively. HIV prevalence was lowest among adolescents than in other age groups in Eswatini (adolescents 11.9%, young 24.2% and older 47.3%), but comparable to young women in Ethiopia (adolescents 1.6%, young 1.6% and older 2.2%) and Mozambique (adolescents 2.5%, young 2.5% and older 5.8%), However, in each of the three countries, lower proportions of adolescents knew their HIV-positive status before ANC enrollment compared to other age groups: in Eswatini (adolescents 51.3%, young 59.9% and older 79.2%), in Ethiopia (adolescents 42.9%, young 63.7% and older 75.2%), and in Mozambique (adolescents 16.4%, young 33.2% and older 45.6%). CONCLUSION: Overall, adolescents made up nearly one-quarter of the women examined and had the least knowledge of their HIV status at ANC enrollment. Their HIV prevalence and known HIV-positive status varied widely across the countries examined. Adolescent-friendly sexual and reproductive health, and PMTCT services, before pregnancy, are needed to improve knowledge of HIV status and support pregnant adolescents and their infants. Antenatal care (ANC) clinics are important for HIV testing of pregnant adolescents, who may not know their HIV-positive status at the first ANC visit. We describe data on pregnant adolescents and women in other age groups in ANC services to examine their prior HIV status at ANC enrollment across three African countries. We examined data from 419 PMTCT sites in Eswatini, Ethiopia, and Mozambique from January-December 2018, to evaluate HIV testing results for adolescents, young and older women aged 15-19, 20-24 and 25-49 years, respectively. We report the number of women living with HIV and the proportions of known and newly identified women living with HIV, by age-group and country. Across three countries, 488,121 women attended ANC and 23,917 (4.9%) were living with HIV. Adolescents constituted 22% of all ANC attendees, whereas young and older women represented 33% and 45%, respectively. HIV prevalence in each country compared to other age groups was lowest and varied among adolescents from 11.9% in Eswatini, to 1.6% in Ethiopia and to 2.5% in Mozambique. Also, fewer adolescents knew their HIV-positive status before ANC enrollment compared to young and older women from 51.3% in Eswatini, 42.9% in Ethiopia to only 16.4% in Mozambique. Pregnant adolescents made up nearly one-quarter of all ANC attendees; a majority of them had no previously known HIV-positive status. Adolescent-friendly, sexual and reproductive health services, before pregnancy and in PMTCT services, are needed to support pregnant adolescents and their infants.

Emerging priorities for HIV service delivery.

Nathan Ford and co-authors discuss global priorities in the provision of HIV prevention and treatment services.

Gender, HIV-Related Stigma, and Health-Related Quality of Life Among Adults Enrolling in HIV Care in Tanzania.

HIV-related stigma has been associated with worse health-related quality of life (HRQoL) among people living with HIV (PLWH). Little is known about how different types of HIV-related stigma (i.e., anticipatory, internalized, or enacted HIV-related stigma) influence HRQoL and whether these relationships differ by gender. The sample included 912 PLWH aged 18 years or older enrolling in HIV care at four health facilities in Tanzania. HRQoL was assessed with the life satisfaction and overall function subscales of the HIV/AIDS-Targeted Quality of Life (HAT-QoL) instrument. Sex-stratified multivariable logistic regression modeled the association of anticipatory, internalized, and enacted HIV-related stigma on poor HRQoL. Across all participants, the mean life satisfaction score was 63.4 (IQR: 43.8, 81.3) and the mean overall function score was 72.0 (IQR: 58.3, 91.7). Mean HRQoL scores were significantly higher for women compared to men for overall function (5.1 points higher) and life satisfaction (4.3 points higher). Fourteen percent of respondents reported recent enacted HIV-related stigma and 13% reported recent medium or high levels of internalized stigma. In multivariable models, high internalized and high anticipatory stigma were significantly associated with higher odds of poor life satisfaction and poor overall function in both men and women. Psychosocial interventions to prevent or reduce the impact of internalized and anticipatory stigma may improve HRQoL among persons in HIV care. Future research should longitudinally examine mechanisms between HIV-related stigma, poor HRQoL, and HIV care outcomes.

Gender Differences and Psychosocial Factors Associated with Problem Drinking Among Adults Enrolling in HIV Care in Tanzania.

Problem drinking is commonly reported among people living with HIV (PLWH), associated with suboptimal HIV care outcomes and differs by gender. Psychosocial factors associated with problem drinking among PLWH remain poorly understood, including whether they differ by gender. This analysis examines the relationship between psychosocial factors and problem drinking separately by gender among PLWH in Tanzania. Cross-sectional data were collected from 812 men and non-pregnant women living with HIV aged 18 or older enrolling in HIV care at four health facilities in Tanzania. Problem drinking was assessed with the CAGE Questionnaire and defined as responding yes to two or more items. Sex-stratified multivariable logistic regression modeled the association of social support, HIV-related stigma, and physical or sexual violence on problem drinking, controlling for age, relationship status, employment, having been away from home for more than  one month, and timing of first HIV-positive diagnosis. Thirteen percent of the sample reported problem drinking, with problem drinking significantly more commonly reported among men than non-pregnant women (17.6% vs. 9.5%). Among men and non-pregnant women, in multivariable analyses, enacted and internalized HIV-related stigma were significantly positively associated with problem drinking. Screening and treatment of problem drinking should be integrated into HIV care. Evidence-based substance abuse interventions should be adapted to address HIV-related stigma. Future research should longitudinally investigate the interrelationships between stigma, violence, and problem drinking among PLWH.

Lay health worker experiences administering a multi-level combination intervention to improve PMTCT retention.

BACKGROUND: The recent scale-up of prevention of mother-to-child transmission of HIV (PMTCT) services has rapidly accelerated antiretroviral therapy (ART) uptake among pregnant and postpartum women in sub-Saharan Africa. The Mother and Infant Retention for Health (MIR4Health) study evaluates the impact of a combination intervention administered by trained lay health workers to decrease attrition among HIV-positive women initiating PMTCT services and their infants through 6 months postpartum. METHODS: This was a qualitative study nested within the MIR4Health trial. MIR4Health was conducted at 10 health facilities in Nyanza, Kenya from September 2013 to September 2015. The trial intervention addressed behavioral, social, and structural barriers to PMTCT retention and included: appointment reminders via text and phone calls, follow-up and tracking for missed clinic visits, PMTCT health education at home visits and during clinic visits, and retention and adherence support and counseling. All interventions were administered by lay health workers. We describe results of a nested small qualitative inquiry which conducted two focus groups to assess the experiences and perceptions of lay health workers administering the interventions. Discussions were recorded and simultaneously transcribed and translated into English. Data were analyzed using framework analysis approach. RESULTS: Study findings show lay health workers played a critical role supporting mothers in PMTCT services across a range of behavioral, social, and structural domains, including improved communication and contact, health education, peer support, and patient advocacy and assistance. Findings also identified barriers to the uptake and implementation of the interventions, such as concerns about privacy and stigma, and the limitations of the healthcare system including healthcare worker attitudes. Overall, study findings indicate that lay health workers found the interventions to be feasible, acceptable, and well received by clients. CONCLUSIONS: Lay health workers played a fundamental role in supporting mothers engaged in PMTCT services and provided valuable feedback on the implementation of PMTCT interventions. Future interventions must include strategies to ensure client privacy, decrease stigma within communities, and address the practical limitations of health systems. This study adds important insight to the growing body of research on lay health worker experiences in HIV and PMTCT care. TRIAL REGISTRATION: Clinicaltrials.gov NCT01962220 .

Reviewing progress: 7 year trends in characteristics of adults and children enrolled at HIV care and treatment clinics in the United Republic of Tanzania.

BACKGROUND: To evaluate the on-going scale-up of HIV programs, we assessed trends in patient characteristics at enrolment and ART initiation over 7 years of implementation. METHODS: Data were from Optimal Models, a prospective open cohort study of HIV-infected (HIV+) adults (≥15 years) and children (<15 years) enrolled from January 2005 to December 2011 at 44 HIV clinics in 3 regions of mainland Tanzania (Kagera, Kigoma, Pwani) and Zanzibar. Comparative statistics for trends in characteristics of patients enrolled in 2005-2007, 2008-2009 and 2010-2011 were examined. RESULTS: Overall 62,801 HIV + patients were enrolled: 58,102(92.5%) adults, (66.5% female); 4,699(7.5%) children.Among adults, pregnant women enrolment increased: 6.8%, 2005-2007; 12.1%, 2008-2009; 17.2%, 2010-2011; as did entry into care from prevention of mother-to-child HIV transmission (PMTCT) programs: 6.6%, 2005-2007; 9.5%, 2008-2009; 12.6%, 2010-2011. WHO stage IV at enrolment declined: 27.1%, 2005-2007; 20.2%, 2008-2009; 11.1% 2010-2011. Of the 42.5% and 29.5% with CD4+ data at enrolment and ART initiation respectively, median CD4+ count increased: 210 cells/µL, 2005-2007; 262 cells/µL, 2008-2009; 266 cells/µL 2010-2011; but median CD4+ at ART initiation did not change (148 cells/µL overall). Stavudine initiation declined: 84.9%, 2005-2007; 43.1%, 2008-2009; 19.7%, 2010-2011.Among children, median age (years) at enrolment decreased from 6.1(IQR:2.7-10.0) in 2005-2007 to 4.8(IQR:1.9-8.6) in 2008-2009, and 4.1(IQR:1.5-8.1) in 2010-2011 and children <24 months increased from 18.5% to 26.1% and 31.5% respectively. Entry from PMTCT was 7.0%, 2005-2007; 10.7%, 2008-2009; 15.0%, 2010-2011. WHO stage IV at enrolment declined from 22.9%, 2005-2007, to 18.3%, 2008-2009 to 13.9%, 2010-2011. Proportion initiating stavudine was 39.8% 2005-2007; 39.5%, 2008-2009; 26.1%, 2010-2011. Median age at ART initiation also declined significantly. CONCLUSIONS: Over time, the proportion of pregnant women and of adults and children enrolled from PMTCT programs increased. There was a decline in adults and children with advanced HIV disease at enrolment and initiation of stavudine. Pediatric age at enrolment and ART initiation declined. Results suggest HIV program maturation from an emergency response.

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.

"They are our eyes outside there in the community": Implementing enhanced training, management and monitoring of South Africa's ward-based primary healthcare outreach teams.

INTRODUCTION: In 2018, South Africa's National Department of Health provided additional resources for ward-based primary healthcare outreach teams (OT) with support from the U.S. President's Emergency Plan for AIDS Relief. The intervention package included a new training curriculum, enhanced staffing, revised management and supervisory structures, and more intensive monitoring and evaluation (M&E). The goal was to strengthen OT and their impact on both primary healthcare and HIV-specific services. We conducted a process evaluation of this intervention package during its second year and examined implementation successes and challenges. METHODS: We conducted a mixed-methods evaluation at 20 purposively selected facilities in Bojanala and City of Tshwane districts, including surveys with 222 community health workers (CHWs) and outreach team leaders (OTLs); key informant interviews and online surveys with 28 policy and program stakeholders; 70 in-depth interviews with health facility staff; 20 focus group discussions with 194 CHWs; 20 structured health facility assessments; directly-observed time-motion studies; and review of program documents. RESULTS: Most participants highlighted the hiring and training of CHWs and OTLs as a key implementation success because this had partially alleviated staffing shortages and helped clarify CHWs' and OTLs' responsibilities and supervisory structures. The new monitoring tools were welcomed for their potential to improve data collection and program tracking. However, participants highlighted many program challenges: short-lived gains in CHWs' knowledge and skills due to lack of ongoing training and mentoring; insufficient integration of OT into health facility management structures; persistent shortages of equipment, supplies, transportation, and workspace for CHWs; and insufficient remuneration for staff. CONCLUSION: Strengthening and expanding CHW programs, such as OT, requires intensive support and continuous investments. To sustain improvements in training, supervision, and job satisfaction, CHWs must be equipped with needed resources, provided with ongoing supportive supervision, and strengthened by optimized program management, monitoring and processes.

Client and healthcare worker experiences with differentiated HIV treatment models in Eswatini.

INTRODUCTION: Universal access to antiretroviral therapy (ART) is a cornerstone of Eswatini's national HIV strategy, and the number of people on ART in the country more than tripled between 2010 and 2019. Building on these achievements, the Ministry of Health (MOH) is scaling up differentiated service delivery, including less-intensive differentiated ART (DART) models for people doing well on treatment. We conducted a mixed-methods study to explore client and health care worker (HCW) perceptions of DART in Eswatini. METHODS: The study included structured site assessments at 39 purposively selected health facilities (HF), key informant interviews with 20 HCW, a provider satisfaction survey with 172 HCW and a client satisfaction survey with 270 adults. RESULTS: All clients had been on ART for more than a year; 69% were on ART for ≥ 5 years. The most common DART models were Fast-Track (44%), Outreach (26%) and Community ART Groups (20%). HCW and clients appreciated DART, noting that the models often decrease provider workload and client wait time. Clients also reported that DART models helped them to adhere to ART, 96% said they were "very satisfied" with their current model, and 90% said they would recommend their model to others, highlighting convenience, efficiency and cost savings. The majority of HCW (52%) noted that implementation of DART reduced their workload, although some models, such as Outreach, were more labor-intensive. Each model had advantages and disadvantages; for example, clients concerned about stigma and inadvertent disclosure of HIV status were less interested in group models. CONCLUSIONS: Clients in DART models were very satisfied with their care. HCW were also supportive of the new approach to HIV treatment delivery, noting its advantages to HF, HCW and to clients. Given the heterogeneous needs of people living with HIV, no single DART model will suit every client; a diverse portfolio of DART models is likely the best strategy.

Optimizing HIV Services for Key Populations in Public-Sector Clinics in Myanmar.

Key populations, ie, female sex workers, men who have sex with men, transgender people, people who inject drugs, and people in prisons and other closed settings, experience stigma, discrimination, and structural barriers when accessing HIV prevention and care. Public health facilities in Myanmar became increasingly involved in HIV service delivery, leading to an urgent need for healthcare workers to provide client-centred, key population-friendly services. Between July 2017-June 2018, the Myanmar Ministry of Health and Sports and National AIDS Programme collaborated with ICAP at Columbia University and the US Centers for Disease Control and Prevention to implement a quasi-experimental, multicomponent intervention including healthcare worker sensitization training with pre- and post- knowledge assessments, healthcare worker and client satisfaction surveys, and structural changes. We observed modest improvements among healthcare workers (n = 50) in knowledge assessments. Classification of clients into key population groups increased and fewer clients were classified as low risk. Key population clients reported favourable perceptions of the quality and confidentiality of care through self-administered surveys. Our findings suggest public health facilities can deliver HIV services that are valued by key population clients.

The role of commercial sex venues in the HIV epidemic among men who have sex with men.

BACKGROUND: Commercial sex venues such as bathhouses and sex clubs have long been considered important facilitators of HIV transmission among men who have sex with men in the United States. Recent probability surveys of commercial-sex-venue patrons in King County, WA that included data on behavior both within and outside these venues provide an empirical basis for the development of mathematical models to estimate the role that commercial sex venues play in the HIV epidemic. METHODS: We constructed deterministic compartmental mathematical models of HIV transmission to estimate both current incidence among King County men who have sex with men and incidence in 5 counterfactual scenarios in which commercial-sex-venues were presumed not to exist. We parameterized the models using a range of values for the proportion of commercial sex venues partnerships replaced in the absence of these venues, and the number of acts of unprotected anal intercourse per other types of partnership. Yearly attributable number was calculated as the difference between incident HIV cases in the main models and each corresponding counterfactual model. We performed extensive sensitivity analyses using Latin hypercube sampling. RESULTS: Replacement of 25% of commercial sex venue partners in the absence of these venues resulted in attributable number values near zero per year. Replacement of 50% or more of commercial sex venue partners resulted in negative yearly attributable numbers, indicating a net increase in incident HIV infections in the absence of these venues. Results of the sensitivity analyses were consistent with the main findings. CONCLUSIONS: Our findings imply that commercial sex venues contribute little to the burden of HIV among men who have sex with men in King County, WA.

HIV risk associated with gay bathhouses and sex clubs: findings from 2 seattle surveys of factors related to HIV and sexually transmitted infections.

OBJECTIVES: We studied the HIV risk behaviors of patrons of the 3 commercial sex venues for men in Seattle, Washington. METHODS: We conducted cross-sectional, observational surveys in 2004 and 2006 by use of time-venue cluster sampling with probability proportional to size. Surveys were anonymous and self-reported. We analyzed the 2004 data to identify patron characteristics and predictors of risk behaviors and compared the 2 survey populations. RESULTS: Fourteen percent of respondents reported a previous HIV-positive test, 14% reported unprotected anal intercourse, and 9% reported unprotected anal intercourse with a partner of unknown or discordant HIV status during the current commercial sex venue visit. By logistic regression, recent unprotected anal intercourse outside of a commercial sex venue was independently associated with unprotected anal intercourse. Sex venue site and patron drug use were strongly associated with unprotected anal intercourse at the crude level. The 2004 and 2006 survey populations did not differ significantly in demographics or behaviors. CONCLUSIONS: Patron and venue-specific characteristics factors may each influence the frequency of HIV risk behaviors in commercial sex venues. Future research should evaluate the effect of structural and individual-level interventions on HIV transmission.

Effectiveness of a Lay Counselor-Led Combination Intervention for Retention of Mothers and Infants in HIV Care: A Randomized Trial in Kenya.

BACKGROUND: Retention of mothers and infants across the prevention of mother-to-child HIV transmission (PMTCT) continuum remains challenging. We assessed the effectiveness of a lay worker administered combination intervention compared with the standard of care (SOC) on mother-infant attrition. METHODS: HIV-positive pregnant women starting antenatal care at 10 facilities in western Kenya were randomized using simple randomization to receive individualized health education, retention/adherence support, appointment reminders, and missed visit tracking vs. routine care per guidelines. The primary endpoint was attrition of mother-infant pairs at 6 months postpartum. Attrition was defined as the proportion of mother-infant pairs not retained in the clinic at 6 months postpartum because of mother or infant death or lost to follow-up. Intent-to-treat analysis was used to assess the difference in attrition. This trial is registered with ClinicalTrials.gov; NCT01962220. RESULTS: From September 2013 to June 2014, 361 HIV-positive pregnant women were screened, and 340 were randomized to the intervention (n = 170) or SOC (n = 170). Median age at enrollment was 26 years (interquartile range 22-30); median gestational age was 24 weeks (interquartile range 17-28). Overall attrition of mother-infant pairs was 23.5% at 6 months postpartum. Attrition was significantly lower in the intervention arm compared with SOC (18.8% vs. 28.2%, relative risk (RR) = 0.67, 95% confidence interval: 0.45 to 0.99, P = 0.04). Overall, the proportion of mothers who were retained and virally suppressed (<1000 copies/mL) at 6 months postpartum was 54.4%, with no difference between study arms. CONCLUSIONS: Provision of a combination intervention by lay counselors can decrease attrition along the PMTCT cascade in low-resource settings.

Engagement in care among women and their infants lost to follow-up under Option B+ in eSwatini.

BACKGROUND: Universal antiretroviral treatment (ART) for pregnant women with HIV, Option B+, has been adopted widely for prevention of mother-to-child HIV transmission (PMTCT). Some evidence shows high loss to follow-up (LTF) under this model. However, gaps in data systems limit this evidence. We collected additional information for women and infants LTF from Option B+ in Eswatini to assess more accurate outcomes. METHODS: LTF at 6-months postpartum was assessed using facility data. Additional data was gathered from: 1) the national ART database and paper records; 2) patient tracing; and 3) interviews and abstraction from patient-held records. Engagement in care was defined as any clinic visit within 91 days before or after 6-months postpartum or completion of a documented transfer; or, for those traced but not completing study interviews, visits at 6-months postpartum or later (for infants), or visits within 3-months of tracing (for women). Multivariable loglinear models were used to identify correlates of engagement. RESULTS: One-hundred-ninety-four (44.7%) of 434 LTF women had outcomes ascertained, including 122 (62.9%) women engaged in care. Among 510 LTF infants, 265 (52.0%) had ascertained outcomes, including 143 (54.0%) engaged in care, 47 (17.7%) pregnancy losses, and 18 (6.8%) deaths. Seventy-two of 189 live infants (38.1%) with ascertained outcomes had a 6-week early infant diagnostic (EID) test. Among women with ascertained outcomes, gestational age of 20+ weeks (vs. fewer than 20 weeks, aRR 0.80; 95% CI 0.68-0.94) and age 25-29 years (vs. 15-24 years, aRR 0.81; 95% CI 0.67-0.97), were associated with lower engagement; initiating ART after first ANC visit was associated with higher engagement (vs. at first ANC visit, aRR 1.12; 95% CI 1.04-1.21). Among infants with ascertained outcomes, mother not initiating ART was associated with lower engagement (vs. ART at first ANC visit, aRR 0.71; 95% CI 0.54-0.91). CONCLUSION: Substantial numbers of women and infants classified as LTF under Option B+ were engaged in care, though a suboptimal level of 6-week EID testing was observed. These findings highlight a need to improve coverage of routine EID testing, and improve data systems to better capture PMTCT patient outcomes.

A pragmatic approach to monitor and evaluate implementation and impact of differentiated ART delivery for global and national stakeholders.

INTRODUCTION: The World Health Organization's (WHO) recommendation of "Treat All" has accelerated the call for differentiated antiretroviral therapy (ART) delivery, a method of care that efficiently uses limited resources to increase access to HIV treatment. WHO has further recommended that stable individuals on ART receive refills every 3 to 6 months and attend clinical visits every 3 to 6 months. However, there is not yet consensus on how to ensure that the quality of services is maintained as countries strive to meet these standards. This commentary responds to this gap by defining a pragmatic approach to the monitoring and evaluation (M&E) of the scale up of differentiated ART delivery for global and national stakeholders. DISCUSSION: Programme managers need to demonstrate that the scale up of differentiated ART delivery is achieving the desired effectiveness and efficiency outcomes to justify continued support by national and global stakeholders. To achieve this goal, the two existing global WHO HIV treatment indicators of ART retention and viral suppression should be augmented with two broad aggregate measures. The addition of indicators measuring the frequency of (1) clinical and (2) refill visits by PLHIV per year will allow evaluation of the pace of scale up while monitoring its overall effect on the quality and efficiency of services. The combination of these four routinely collected aggregate indicators will also facilitate the comparison of outcomes among facilities, regions or countries implementing different models of ART delivery. Enhanced monitoring or additional assessments will be required to answer other critical questions on the process of implementation, acceptability, effectiveness and efficiency. CONCLUSIONS: These proposed outcomes are useful markers for the effectiveness and efficiency of the health system's attempts to deliver quality treatment to those who need it-and still reserve as much of the available resource pool as possible for other key elements of the HIV response.

Mother Infant Retention for Health (MIR4Health): Study Design, Adaptations, and Challenges With PMTCT Implementation Science Research.

BACKGROUND: Effective retention of HIV-infected mothers and their infants is fraught with multiple challenges, resulting in loss across the continuum of prevention of mother-to-child HIV transmission (PMTCT) care and missed opportunities to offer life-saving HIV prevention and treatment. METHODS: The Mother Infant Retention for Health study is an individual-randomized study evaluating the effectiveness of active patient follow-up compared with standard of care on the combined outcome of attrition of HIV-infected women and their infants at 6 months postpartum. Lay counselors administered the active patient follow-up package of interventions, including individualized health education, use of flip charts during clinic visits, and at home, phone and short message service appointment reminders, active phone and physical tracking of patients immediately after missed clinic visits, and individualized retention and adherence support. RESULTS: Use of study visits to indicate participant progression along the PMTCT cascade highlights the nature of loss among women and infants in PMTCT care because of issues such as pregnancy complications, infant deaths, and transfer out. Delay in implementation of Option B+, unanticipated slow enrollment, a health-care worker strike, rapid HIV test kit shortages, and changes in national PMTCT guidelines necessitated several modifications to the protocol design and implementation to ensure successful completion of the study. CONCLUSIONS: Flexibility when operationalizing an implementation science study is critical in the context of the shifting landscape in a noncontrolled "real-world" setting. TRIAL REGISTRATION: Clinicaltrials.gov NCT01962220.

Decentralization of HIV care and treatment services in Central Province, Kenya.

BACKGROUND: Since 2006, the government of Kenya began decentralizing HIV care from secondary health facilities (SHF) to an expanded network, including primary health facilities (PHF). We evaluated the impact of this strategy on enrollment, care, and outcomes among adult patients in Central Province, Kenya, from 2006 to 2010. METHODS: We analyzed electronic patient-level data for 26,690 patients at 15 SHF and 22 PHF. Enrollment, patient, and facility characteristics and patterns in CD4 testing, World Health Organization staging, and antiretroviral treatment (ART) initiation were compared between SHF and PHF. Survival analysis was used to estimate cumulative death and loss to follow-up (LTF) rates in PHF and SHF. Multivariate competing risks regression and Cox proportional hazards models were constructed to identify correlates of LTF and death. RESULTS: Enrollment in PHF increased mainly between 2007 and 2009, representing 5% and 25% of all new enrollments, respectively. CD4 test provision and World Health Organization staging, time to ART initiation, and CD4 count at ART initiation were for the most part similar between PHF and SHF. In multivariate analyses, pre-ART patients enrolled in PHF had a lower risk of LTF than those enrolled in SHF (SHR = 0.77, 95% confidence interval: 0.61 to 0.96). No differences in risk of death among pre-ART patients or in LTF or death among ART patients were observed. CONCLUSIONS: Enrollment at PHF increased substantially during the period; death rates were comparable between PHF and SHF, whereas LTF among pre-ART patients was lower at PHF. This suggests that decentralization can be a successful strategy for expanding HIV care.