Effect of index HIV self-testing for sexual partners of clients enrolled in antiretroviral therapy (ART) programs in Malawi: A randomized controlled trial.

BACKGROUND: HIV testing among the sexual partners of HIV-positive clients is critical for case identification and reduced transmission in southern and eastern Africa. HIV self-testing (HIVST) may improve uptake of HIV services among sexual partners of antiretroviral therapy (ART) clients, but the impact of HIVST on partner testing and subsequent ART initiation remains unclear. METHODS AND FINDINGS: We conducted an individually randomized, unblinded trial to assess if an index HIVST intervention targeting the partners of ART clients improves uptake of testing and treatment services in Malawi. The trial was conducted at 3 high-burden facilities in central and southern Malawi. ART clients attending HIV treatment clinics were randomized using simple randomization 1:2·5 to: (1) standard partner referral slip (PRS) whereby ART clients were given facility referral slips to distribute to their primary sexual partners; or (2) index HIVST whereby ART clients were given HIVST kits + HIVST instructions and facility referral slips to distribute to their primary sexual partners. Inclusion criteria for ART clients were: ≥15 years of age, primary partner with unknown HIV status, no history of interpersonal violence (IPV) with partner, and partner lives in facility catchment area. The primary outcome was partner testing 4-weeks after enrollment, reported by ART clients using endline surveys. Medical chart reviews and tracing activities with partners with a reactive HIV test measured ART initiation at 12 months. Analyses were conducted based on modified intention-to-treat principles, whereby we excluded individuals who did not have complete endline data (i.e., were loss to follow up from the study). Adjusted models controlled for the effects of age and marital status. A total of 4,237 ART clients were screened and 484 were eligible and enrolled (77% female) between March 28, 2018 and January 5, 2020. A total of 365 participants completed an endline survey (257/34 index HIVST arm; 107/13 PRS arm) and were included in the final analysis (78% female). Testing coverage among sexual partners was 71% (183/257) in the index HIVST arm and 25% (27/107) in the PRS arm (aRR: 2·77, 95% CI [2·56 to 3·00], p ≤ 0.001). Reported HIV positivity rates did not significantly differ by arm (16% (30/183) in HIVST versus 15% (4/27) in PRS; p = 0.99). ART initiation at 12 months was 47% (14/30) in HIVST versus 75% (3/4) in PRS arms; however, index HIVST still resulted in a 94% increase in the proportion of all partners initiating ART due to higher HIV testing rates in the HIVST arm (5% partners initiated ART in HVIST versus 3% in PRS). Adverse events including IPV and termination of the relationship did not vary by arm (IPV: 3/257 index HIVST versus 4/10 PRS; p = 0.57). Limitations include reliance on secondary report by ART clients, potential social desirability bias, and not powered for sex disaggregated analyses. CONCLUSIONS: Index HIVST significantly increased HIV testing and the absolute number of partners initiating ART in Malawi, without increased risk of adverse events. Additional research is needed to improve linkage to HIV treatment services after HIVST use. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03271307, and Pan African Clinical Trials, PACTR201711002697316.

Strategies to improve antiretroviral therapy (ART) initiation and early engagement among men in sub-Saharan Africa: A scoping review of interventions in the era of universal treatment.

OBJECTIVES: Men in sub-Saharan Africa (SSA) have lower rates of antiretroviral therapy (ART) initiation and higher rates of early default than women. Little is known about effective interventions to improve men's outcomes. We conducted a scoping review of interventions aimed to increase ART initiation and/or early retention among men in SSA since universal treatment policies were implemented. METHODS: Three databases, HIV conference databases and grey literature were searched for studies published between January 2016 to May 2021 that reported on initiation and/or early retention among men. Eligibility criteria included: participants in SSA, data collected after universal treatment policies were implemented (2016-2021), quantitative data on ART initiation and/or early retention for males, general male population (not exclusively focused on key populations), intervention study (report outcomes for at least one non-standard service delivery strategy), and written in English. RESULTS: Of the 4351 sources retrieved, 15 (reporting on 16 interventions) met inclusion criteria. Of the 16 interventions, only two (2/16, 13%) exclusively focused on men. Five (5/16, 31%) were randomised control trials (RCT), one (1/16, 6%) was a retrospective cohort study, and 10 (10/16, 63%) did not have comparison groups. Thirteen (13/16, 81%) interventions measured ART initiation and six (6/16, 37%) measured early retention. Outcome definitions and time frames varied greatly, with seven (7/16, 44%) not specifying time frames at all. Five types of interventions were represented: optimising ART services at health facilities, community-based ART services, outreach support (such as reminders and facility escort), counselling and/or peer support, and conditional incentives. Across all intervention types, ART initiation rates ranged from 27% to 97% and early retention from 47% to 95%. CONCLUSIONS: Despite years of data of men's suboptimal ART outcomes, there is little high-quality evidence on interventions to increase men's ART initiation or early retention in SSA. Additional randomised or quasi-experimental studies are urgently needed.

Triple Benefit: Impact of an Integrated Early Childhood Development and PMTCT Intervention on ART Outcomes Among Mothers Living with HIV and Infants in Malawi-An Endline Evaluation.

We conducted a programmatic, observational cohort study with mother-infant pairs (MIPs) enrolled in prevention-of-mother-to-child-transmission (PMTCT) programs in Malawi to assess the feasibility and potential HIV-related benefits of integrating Early Childhood Development (ECD) services into PMTCT programs. Six health facilities were included in the intervention. We offered ECD counseling from the WHO/UNICEF Care for Child Development package in PMTCT waiting spaces while MIPs waited for PMTCT and broader treatment consultations. Primary outcomes were mothers' retention in HIV care at 12 months and infant HIV testing at 6 weeks and 12 months after birth. Routine facility-level data from six comparison health facilities were collected as an adhoc standard of care comparison and used to calculate the cost of delivering the intervention. A total of 607 MIPs were enrolled in the integrated ECD-PMTCT intervention between June 2018 and December 2019. The average age of MIPs was 30 years and 7 weeks respectively. We found that 86% of mothers attended ≥ 5 of the 8 ECD sessions over the course of 12 months; 88% of intervention mothers were retained in PMTCT versus 59% of mothers in comparison health facilities, and 96% of intervention infants were tested for HIV by six weeks compared to 66% of infants in comparison health facilities. Costing data demonstrated the financial feasibility of integrating ECD and PMTCT programs in government health facilities in Malawi. Integrating ECD into PMTCT programs was feasible, acceptable, resulted in better programmatic outcomes for both mothers and infants. Further investigation is required to determine optimal delivery design for scale-up.

Screening Adults for HIV Testing in the Outpatient Department: An Assessment of Tool Performance in Malawi.

Little is known about screening tools for adults in high HIV burden contexts. We use exit survey data collected at outpatient departments in Malawi (n = 1038) to estimate the sensitivity, specificity, negative and positive predictive values of screening tools that include questions about sexual behavior and use of health services. We compare a full tool (seven relevant questions) to a reduced tool (five questions, excluding sexual behavior measures) and to standard of care (two questions, never tested for HIV or tested > 12 months ago, or seeking care for suspected STI). Suspect STI and ≥ 3 sexual partners were associated with HIV positivity, but had weak sensitivity and specificity. The full tool (using the optimal cutoff score of ≥ 3) would achieve 55.6% sensitivity and 84.9% specificity for HIV positivity; the reduced tool (optimal cutoff score ≥ 2) would achieve 59.3% sensitivity and 68.5% specificity; and standard of care 77.8% sensitivity and 47.8% specificity. Screening tools for HIV testing in outpatient departments do not offer clear advantages over standard of care.

Gendered differences in perceptions and reports of wellbeing: A cross-sectional survey of adults on ART in Malawi.

Few studies have examined gender differences in reported quality of life among persons living with HIV (PLWH) in low-income countries. We conducted a cross-sectional survey of adults on antiretroviral therapy in Malawi, including questions focused on wellbeing, and collected clinical data on these respondents. We compared men's and women's self-reported health and wellbeing using Poisson models that included socio-demographic covariates. Approximately 20% of respondents reported at least one physical functioning problem. In multiple variable models, men were significantly more likely to have a high viral load (≥200 copies/mL; aIRR 2.57), consume alcohol (aIRR 12.58), receive no help from family or friends (aIRR 2.18), and to feel worthless due to their HIV status (aIRR 2.40). Men were significantly less likely to be overweight or obese (aIRR 0.31), or report poor health (health today is not "very good;" aIRR 0.41). Taken together, despite higher prevalence of poor self-rated health, women were healthier across a range of objective dimensions, with better viral suppression, less alcohol use, and less social isolation (although they were more likely to have an unhealthy BMI). Research that includes multi-dimensional and gender-specific measurement of physical, mental and social health is important for improving our understanding of well-being of PLWH.

Frequency of visits to health facilities and HIV services offered to men, Malawi.

OBJECTIVE: To determine how often men in Malawi attend health facilities and if testing for human immunodeficiency virus (HIV) is offered during facility visits. METHODS: We conducted a cross-sectional, community-representative survey of men (15-64 years) from 36 villages in Malawi. We excluded men who ever tested HIV-positive. Primary outcomes were: health facility visits in the past 12 months (for their own health (client visit) or to support the health services of others (guardian visit)); being offered HIV testing during facility visits; and being tested that same day. We disaggregated all results by HIV testing history: tested ≤ 12 months ago, or in need of testing (never tested or tested > 12 months before). FINDINGS: We included 1116 men in the analysis. Mean age was 34 years (standard deviation: 13.2) and 55% (617/1116) of men needed HIV testing. Regarding facility visits, 82% (920/1116) of all men and 70% (429/617) of men in need of testing made at least one facility visit in the past 12 months. Men made a total of 1973 visits (mean two visits): 39% (765/1973) were as guardians and 84% (1657/1973) were to outpatient departments. Among men needing HIV testing, only 7% (30/429) were offered testing during any visit. The most common reason for not testing was not being offered services (37%; 179/487). CONCLUSION: Men in Malawi attend health facilities regularly, but few of those in need of HIV testing are offered testing services. Health screening services should capitalize on men's routine visits to outpatient departments as clients and guardians.

Barriers and facilitators to facility HIV self-testing in outpatient settings in Malawi: a qualitative study.

BACKGROUND: Facility HIV self-testing (HIVST) within outpatient departments can increase HIV testing coverage by facilitating HIVST use in outpatient waiting spaces while clients wait for routine care. Facility HIVST allows for the majority of outpatients to test with minimal health care worker time requirements. However, barriers and facilitators to outpatients' use of facility HIVST are still unknown. METHODS: As part of a cluster randomized trial on facility HIVST in Malawi, we conducted in-depth interviews with 57 adult outpatients (> 15 years) who were exposed to the HIVST intervention and collected observational journals that documented study staff observations from facility waiting spaces where HIVST was implemented. Translated and transcribed data were analyzed using constant comparison analysis in Atlas.ti. RESULTS: Facility HIVST was convenient, fast, and provided autonomy to outpatients. The strategy also had novel facilitators for testing, such as increased motivation to test due to seeing others test, immediate support for HIVST use, and easy access to additional HIV services in the health facility. Barriers to facility HIVST included fear of judgment from others and unwanted status disclosure due to lack of privacy. Desired changes to the intervention included private, separate spaces for kit use and interpretation and increased opportunity for disclosure and post-test counseling. CONCLUSIONS: Facility HIVST was largely acceptable to outpatients in Malawi with novel facilitators that are unique to facility HIVST in OPD waiting spaces. TRIAL REGISTRATION: The parent trial is registered with ClinicalTrials.gov , NCT03271307 , and Pan African Clinical Trials, PACTR201711002697316.

Integrated early childhood development services improve mothers' experiences with prevention of mother to child transmission (PMTCT) programs in Malawi: a qualitative study.

BACKGROUND: HIV-positive mothers who face the dual burden of HIV-positive status and motherhood, may benefit from holistic services that include early childhood development (ECD). We evaluated the acceptability and impact of integrated ECD-PMTCT interventions for mothers and their children. METHODS: We implemented an integrated ECD-PMTCT intervention in 4 health facilities in Malawi for HIV-positive mothers and their infants. WHO/UNICEF Care for Child Development (CCD) education and counseling sessions were offered during routine PMTCT visits between infant age 1.5-24 months. From June-July 2019, we conducted in-depth interviews with 29 mothers enrolled in the intervention for ≥6 months across 4 health facilities. The interview guide focused on perceived impact of the intervention on mothers' ECD and PMTCT practices, including barriers and facilitators, and unmet needs related to the program. Data were coded and analyzed using constant comparison methods in Atlas ti.8. RESULTS: The vast majority of mothers believed the ECD-PMTCT intervention improved their overall experience with the PMTCT services, strengthened their relationship with providers, and excited and motivated them to attend PMTCT services during the postpartum period. Unlike prior experience, mothers felt more welcome at the health facility, and looked forward to the next visit in order to interact with other mothers and learn new ECD skills. Mothers formed new social support networks with other mothers engaged in ECD sessions, and they provided emotional and financial support to one another, including encouragement regarding ART adherence. Mothers believed their infants reached developmental milestones faster compared to non-intervention children they observed at the same age, and they experienced improved engagement in caregiving activities among male caregivers. Nearly half of women requested additional support with depression or anxiety, coping mechanisms to deal with the stresses of life, or support in building positive dynamics with their male partner. CONCLUSION: The integrated ECD-PMTCT intervention improved mother's experiences with PMTCT programs and health care providers, increased ECD practices such as responsive and stimulating parenting, and created social support networks for women with other PMTCT clients.

Integrating HIV and hypertension management in low-resource settings: Lessons from Malawi.

Pragna Patel and colleagues describe the implementation of a hypertension management model for HIV-infected people in Malawi.

Status of HIV Epidemic Control Among Adolescent Girls and Young Women Aged 15-24 Years - Seven African Countries, 2015-2017.

In 2016, an estimated 1.5 million females aged 15-24 years were living with human immunodeficiency virus (HIV) infection in Eastern and Southern Africa, where the prevalence of HIV infection among adolescent girls and young women (3.4%) is more than double that for males in the same age range (1.6%) (1). Progress was assessed toward the Joint United Nations Programme on HIV/AIDS (UNAIDS) 2020 targets for adolescent girls and young women in sub-Saharan Africa (90% of those with HIV infection aware of their status, 90% of HIV-infected persons aware of their status on antiretroviral treatment [ART], and 90% of those on treatment virally suppressed [HIV viral load <1,000 HIV RNA copies/mL]) (2) using data from recent Population-based HIV Impact Assessment (PHIA) surveys in seven countries. The national prevalence of HIV infection in adolescent girls and young women aged 15-24 years, the percentage who were aware of their status, and among those persons who were aware, the percentage who had achieved viral suppression were calculated. The target for viral suppression among all persons with HIV infection is 73% (the product of 90% x 90% x 90%). Among all seven countries, the prevalence of HIV infection among adolescent girls and young women was 3.6%; among those in this group, 46.3% reported being aware of their HIV-positive status, and 45.0% were virally suppressed. Sustained efforts by national HIV and public health programs to diagnose HIV infection in adolescent girls and young women as early as possible to ensure rapid initiation of ART should help achieve epidemic control among adolescent girls and young women.