Facility HIV Self-Testing in Outpatient Departments: An Assessment of Characteristics and Concerns of Outpatients Who Opt Out of Testing in Malawi.

BACKGROUND: Facility HIV self-testing (HIVST) in outpatient departments can dramatically increase testing among adult outpatients. However, it is still unclear why populations opt out of facility HIVST and reasons for opt outing. Using data from a parent facility HIVST trial, we sought to understand individual characteristics associated with opting out of facility HIVST and reported reasons for not testing. METHODS: Exit surveys were conducted with outpatients aged ≥15 years at 5 facilities in Central and Southern Malawi randomized to the facility HIVST arm of the parent trial. Outpatients were eligible for our substudy if they were offered HIVST and eligible for HIV testing (ie, never previously tested HIV positive and tested ≥12 months ago or never tested). Summary statistics and multivariate regression models were used. RESULTS: Seven hundred seventy-one outpatients were included in the substudy. Two hundred sixty-three (34%) opted out of HIVST. Urban residency (adjusted risk ratios [aRR] 3.48; 95% CI: 1.56 to 7.76) and self-reported poor health (aRR 1.86; 95% CI: 1.27 to 2.72) were associated with an increased risk of opting out. Male participants had a 69% higher risk of opting out (aRR 1.69; 95% CI: 1.14 to 2.51), with risk being 38% lower among working male participants. Primary reasons for not testing were feeling unprepared to test (49·4%) and perceived low risk of HIV infection (30·4%)-only 2.6% believed that HIVST instructions were unclear, and 1.7% were concerned about privacy. CONCLUSION: Working, risky sexual behavior, rural residence, and good self-rated health were positively associated with opting out of HIVST among outpatients. Strategies to address internalized barriers, such as preparedness to test and perceived need to test, should be incorporated into facility HIVST interventions.

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.

Stakeholder Priorities for ART Initiation and Early Retention Interventions in Malawi: A Qualitative Study Comparing International and National Perspectives.

Background: New or returning ART clients are often ineligible for differentiated service delivery (DSD) models, though they are at increased risk of treatment interruption and may benefit greatly from flexible care models. Stakeholder support may limit progress on development and scale-up of interventions for this population. We qualitatively explored stakeholder perceptions of and decision-making criteria regarding DSD models for new or returning ART clients in Malawi. Methods: We conducted in-depth interviews with internationally based stakeholders (from foundations, multilateral organizations, and NGOs) and Malawi-based stakeholders (from the Malawi Ministry of Health and PEPFAR implementing partners). The interviews included two think-aloud scenarios in which participants rated and described their perceptions of 1) the relative importance of five criteria (cost, effectiveness, acceptability, feasibility, and equity) in determining which interventions to implement for new or returning ART clients and 2) their relative interest in seven potential interventions (monetary incentives, nonmonetary incentives, community-based care, ongoing peer/mentor support and counseling, eHealth, facility-based interventions, and multimonth dispensing) for the same population. The interviews were completed in English via video conference and were audio-recorded. Transcriptions were coded using ATLAS.ti version 9. We examined the data using thematic content analysis and explored differences between international and national stakeholders. Results: We interviewed twenty-two stakeholders between October 2021 and March 2022. Thirteen were based internationally, and nine were based in Malawi. Both groups prioritized client acceptability but diverged on other criteria: international stakeholders prioritized effectiveness, and Malawi-based stakeholders prioritized cost, feasibility, and sustainability. Both stakeholder groups were most interested in facility-based DSD models, such as multimonth dispensing and extended facility hours. Nearly all the stakeholders described person-centered care as a critical focus for any DSD model implemented. Conclusions: National and international stakeholders support DSD models for new or returning ART clients. Client acceptability and long-term sustainability should be prioritized to address the concerns of nationally based stakeholders. Future studies should explore the reasons for differences in national and international stakeholders' priorities and how to ensure that local perspectives are incorporated into funding and programmatic decisions.

Men care too: a qualitative study examining women's perceptions of fathers' engagement in early childhood development (ECD) during an ECD program for HIV-positive mothers in Malawi.

OBJECTIVES: Integrated early childhood development (ECD) and prevention of mother-to-child transmission (PMTCT) interventions rarely target fathers, a missed opportunity given existing research demonstrating that father involvement improves maternal and child outcomes. We aimed to explore mother's perceptions of fathers' buy-in to an integrated PMTCT-ECD programme, any impact the programme had on couple dynamics, and perceived barriers to fathers' involvement in ECD activities. DESIGN: Qualitative study using individual in-depth interviews with mothers participating in a PMTCT-ECD programme. Interviews assessed mothers' perceptions of father buy-in and engagement in the programme and ECD activities. Data were coded using inductive and deductive strategies and analysed using constant comparison methods in Atlas.ti V.1.6. SETTING: Four health facilities in Malawi where PMTCT services were provided. PARTICIPANTS: Study participants were mothers infected with HIV who were enrolled in the PMTCT-ECD programme for >6 months. INTERVENTIONS: The PMTCT-ECD intervention provided ECD education and counselling sessions during routine PMTCT visits for mothers infected with HIV and their infants (infant age 1.5-24 months). The intervention did not target fathers, but mothers were encouraged to share information with them. RESULTS: Interviews were conducted with 29 mothers. Almost all mothers discussed the PMTCT-ECD intervention with male partners. Most mothers reported that fathers viewed ECD as valuable and practised ECD activities at home. Several reported improved partner relationships and increased communication due to the intervention. However, most mothers believed fathers would not attend the PMTCT-ECD intervention due to concerns regarding HIV-related stigma at PMTCT clinics, time required to attend and perceptions that the intervention was intended for women. CONCLUSIONS: Fathers were interested in an integrated PMTCT-ECD programme and actively practised ECD activities at home, but felt uncomfortable visiting PMTCT clinics. Interventions should consider direct community outreach or implementing ECD programmes at facility entry points where men frequent, such as outpatient departments.

Association of HIV status and treatment characteristics with VIA screening outcomes in Malawi: A retrospective analysis.

BACKGROUND: Although evidence from high-resource settings indicates that women with HIV are at higher risk of acquiring high-risk HPV and developing cervical cancer, data from cervical cancer "screen and treat" programs using visual inspection with acetic acid (VIA) in lower-income countries have found mixed evidence about the association between HIV status and screening outcomes. Moreover, there is limited evidence regarding the effect of HIV-related characteristics (e.g., viral suppression, treatment factors) on screening outcomes in these high HIV burden settings. METHODS: This study aimed to evaluate the relationship between HIV status, HIV treatment, and viral suppression with cervical cancer screening outcomes. Data from a "screen and treat" program based at a large, free antiretroviral therapy (ART) clinic in Lilongwe, Malawi was retrospectively analyzed to determine rates of abnormal VIA results and suspected cancer, and coverage of same-day treatment. Multivariate logistic regression assessed associations between screening outcomes and HIV status, and among women living with HIV, viremia, ART treatment duration and BMI. RESULTS: Of 1405 women receiving first-time VIA screening between 2017-2019, 13 (0.9%) had suspected cancer and 68 (4.8%) had pre-cancerous lesions, of whom 50 (73.5%) received same-day lesion treatment. There was no significant association found between HIV status and screening outcomes. Among HIV+ women, abnormal VIA was positively associated with viral load ≥ 1000 copies/mL (aOR 3.02, 95% CI: 1.22, 7.49) and negatively associated with ART treatment duration (aOR 0.88 per additional year, 95% CI: 0.80, 0.98). CONCLUSION: In this population of women living with HIV with high rates of ART coverage and viral suppression, HIV status was not significantly associated with abnormal cervical cancer screening results. We hypothesize that ART treatment and viral suppression may mitigate the elevated risk of cervical cancer for women living with HIV, and we encourage further study on this relationship in high HIV burden settings.

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.

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.

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.

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.

Evidence on the effectiveness of community-based primary health care in improving HIV/AIDS outcomes for mothers and children in low- and middle-income countries: Findings from a systematic review.

BACKGROUND: The effectiveness of community-based primary health care (CBPHC) interventions in low- and middle-income countries (LMICs), especially for maternal, neonatal and child health, is well established. However, there has not been a systematic review of the literature on the effectiveness of CBPHC on HIV outcomes derived from rigorous assessments of primary studies. Using peer-reviewed studies of randomized interventions or those containing a specified control group and directly measuring clinical HIV outcomes, we provide evidence for the effectiveness of CBPHC on HIV outcomes for mothers and children in low- and middle-income countries (LMICs). METHODS: Eligibility criteria included studies assessing the effectiveness of community-based HIV interventions with or without a facility-based component, or multiple integrated projects, with outcome measures defining an aspect of HIV health status such as the utilization of prevention or health care services, nutritional status, serious morbidity (including clinical measures of HIV progression) or mortality of children aged five or younger and pregnant women. Articles published through June 3, 2020 were identified by searching four databases. The type of community-based projects implemented, the implementors, and the implementation strategies of each program were identified and the impact on HIV-related outcomes assessed. RESULTS: The search yielded 10 537 articles; 4881 underwent title and abstract screening after removing duplicates. Of these, 117 studies qualified for full-text screening; only 22 were included in the final analysis. Most studies showed that community-based interventions improved HIV prevention and treatment outcomes compared to facility-based approaches alone. Each study had at least one statistically significant HIV-related outcome; the non-significant outcomes found in six of the 22 studies were mostly not related to HIV programming. Most interventions were implemented by community health workers; other implementers were government workers, community members, or research staff. Strategies used included peer-to-peer education, psychosocial support, training of community champions, community-based follow-up care, home-based care, and integrated care. CONCLUSIONS: CBPHC strategies are effective in improving population-based, HIV-related health outcomes for mothers and children, especially in combination with facility-based approaches. However, there is a need to assess the scalability of such interventions and integrate them into existing health systems to assess their impact on the HIV pandemic in more routine settings.

Multimonth dispensing of up to 6 months of antiretroviral therapy in Malawi and Zambia (INTERVAL): a cluster-randomised, non-blinded, non-inferiority trial.

BACKGROUND: Facility-based, multimonth dispensing of antiretroviral therapy (ART) for HIV could reduce burdens on patients and providers and improve retention in care. We assessed whether 6-monthly ART dispensing was non-inferior to standard of care and 3-monthly ART dispensing. METHODS: We did a pragmatic, cluster-randomised, unblinded, non-inferiority trial (INTERVAL) at 30 health facilities in Malawi and Zambia. Eligible participants were aged 18 years or older, HIV-positive, and were clinically stable on ART. Before randomisation, health facilities (clusters) were matched on the basis of country, ART cohort size, facility type (ie, hospital vs health centre), and region or province. Matched clusters were randomly allocated (1:1:1) to standard of care, 3-monthly ART dispensing, or 6-monthly ART dispensing using a simple random allocation sequence. The primary outcome was retention in care at 12 months, defined as the proportion of patients with less than 60 consecutive days without ART during study follow-up, analysed by intention to treat. A 2·5% margin was used to assess non-inferiority. This study is registered with ClinicalTrials.gov, NCT03101592. FINDINGS: Between May 15, 2017, and April 30, 2018, 9118 participants were randomly assigned, of whom 8719 participants (n=3012, standard of care group; n=2726, 3-monthly ART dispensing group; n=2981, 6-monthly ART dispensing group) had primary outcome data available at 12 months and were included in the primary analysis. The median age of participants was 42·7 years (IQR 36·1-49·9) and 5774 (66·2%) of 8719 were women. The primary outcome was met by 2478 (82·3%) of 3012 participants in the standard of care group, 2356 (86·4%) of 2726 participants in the 3-monthly ART dispensing group, and 2729 (91·5%) of 2981 participants in the 6-monthly ART dispensing group. After adjusting for clustering, for retention in care at 12 months, the 6-monthly ART dispensing group was non-inferior to the standard of care group (percentage-point increase 9·1 [95% CI 0·9-17·2]) and to the 3-monthly ART dispensing group (5·0% [1·0-9·1]). INTERPRETATION: Clinical visits with ART dispensing every 6 months was non-inferior to standard of care and 3-monthly ART dispensing. 6-monthly ART dispensing is a promising strategy for the expansion of ART provision and achievement of HIV treatment targets in resource-constrained settings. FUNDING: US Agency for International Development.

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.

Applying Structural Equation Modeling to Measure Violence Exposure and Its Impact on Mental Health: Malawi Violence Against Children and Young Women Survey, 2013.

This study examines exposure to multiple forms of violence among Malawian children and youth and their association with mental health outcomes. The Malawi Violence Against Children and Young Women Survey was conducted among a nationally representative sample of males and females aged 13 to 24 years (n = 2,162) in Malawi in 2013. The experience of sexual, physical, and emotional violence prior to age 18 and during the past 12 months and associated health outcomes were ascertained using a comprehensive interview. Latent factors of sexual violence, physical violence, and emotional violence as well as psychological distress were constructed. We examined whether the experience of violence was related to psychological distress after controlling for age and gender. Violence exposure prior to age 18 (early life) and during the past 12 months (proximal) were valid indicators for a latent factor representing overall lifetime violence exposure. Females were more likely to experience sexual violence, whereas males were more likely to experience physical violence. Experience of any type of violence decreased with age whereas experience of psychological distress increased with age. Current psychological distress was directly associated with exposure to sexual and emotional violence recently or during childhood. Exposure to multiple forms of violence during lifetime was related to two to seven folds higher odds of experiencing psychological distress compared with those who had never experienced violence. Future intervention strategies should address three forms of violence against children simultaneously in light of the associated adverse mental health outcomes.

Effect of facility-based HIV self-testing on uptake of testing among outpatients in Malawi: a cluster-randomised trial.

BACKGROUND: HIV self-testing increases testing uptake in sub-Saharan Africa but scale-up is challenging because of resource constraints. We evaluated an HIV self-testing intervention integrated into high-burden outpatient departments in Malawi. METHODS: In this cluster-randomised trial, we recruited participants aged 15 years or older from 15 outpatient departments at high-burden health facilities (including health centres, mission hospitals, and district hospitals) in central and southern Malawi. The trial was clustered at the health facility level. We used constrained randomisation to allocate each cluster (1:1:1) to one of the following groups: standard provider-initiated testing and counselling with no intervention (provider offered during consultations), optimised provider-initiated testing and counselling (with additional provider training and morning HIV testing), and facility-based HIV self-testing (Oraquick HIV self-test, group demonstration and distribution, and private spaces for interpretation and counselling). The primary outcome was the proportion of outpatients tested for HIV on the day of enrolment, measured through exit surveys with a sample of outpatients. Analyses were on an intention-to-treat basis. The trial is registered with ClinicalTrials.gov, NCT03271307, and Pan African Clinical Trials, PACTR201711002697316. FINDINGS: Between Sept 12, 2017, and Feb 23, 2018, 5885 outpatients completed an exit survey-2097 in the HIV self-testing group, 1951 in the standard provider-initiated testing and counselling group, and 1837 in the optimised provider-initiated testing and counselling group. 1063 (51%) of 2097 patients in the HIV self-testing group had HIV testing on the same day as enrolment, compared with 248 (13%) of 1951 in the standard provider-initiated testing and counselling group and 261 (14%) of 1837 in the optimised provider-initiated testing and counselling group. The odds of same-day HIV testing were significantly higher in the facility-based HIV self-testing group compared with either standard provider-initiated testing and counselling (adjusted odds ratio 8·52, 95% CI 3·98-18·24) or optimised provider-initiated testing and counselling (6·29, 2·96-13·38). Around 4% of those tested in the standard provider-initiated testing and counselling and optimised provider-initiated testing and counselling groups felt coerced to test, and around 1% felt coerced to share test results. No coercion was reported in the facility-based HIV self-testing group. INTERPRETATION: Facility-based HIV self-testing increased HIV testing among outpatients in Malawi, with a minimal risk of adverse events. Facility-based HIV self-testing should be considered for scale-up in settings with a high unmet need for HIV testing. FUNDING: United States Agency for International Development.

National estimates and risk factors associated with early mother-to-child transmission of HIV after implementation of option B+: a cross-sectional analysis.

BACKGROUND: Routine data from Malawi's prevention of mother-to-child transmission (MTCT) option B+ programme suggest high uptake of antiretroviral therapy (ART) among pregnant women. Malawi's Ministry of Health led the National Evaluation of Malawi's PMTCT Program to obtain nationally representative data on maternal ART coverage and prevention of MTCT effectiveness. Here, we present the early transmission data for infants aged 4-12 weeks. METHODS: We used a multistage cluster design to recruit a nationally representative sample of HIV-exposed infants and their mothers in Malawi. Between October 16, 2014, and May 17, 2016, we screened for HIV in all mothers attending an under-5 vaccination or outpatient sick-child clinic with infants aged 4-26 weeks at 54 health facilities selected across ten districts and four regional sampling zones. Infants with mothers identified as HIV-infected were enrolled in the cohort. We calculated weighted MTCT rates for only the subset of infants aged 4-12 weeks at screening, thereby capturing MTCT from early pregnancy, to delivery, and early breastfeeding. We collected data on maternal and infant demographics and self-reported use of HIV services, ART, and antenatal clinics. We tested HIV-exposed infants for the virus and assessed associations of certain variables with infant HIV status. FINDINGS: We confirmed HIV exposure in 3542 (10·4%) of 33 980 mother (guardian)-infant pairs with infants aged 4-26 weeks. Of those, 2530 (2514 mothers and 16 guardians) had infants aged 4-12 weeks at the time of screening (2498 singlets and 32 twins). We excluded 25 infants from the analysis because no information was available about their HIV status. 91·3% (95% CI 85·6-96·9) of mothers were on ART during pregnancy. The MTCT rate was 3·7% (2·3-6·0) overall and ranged from 1·4% (0·4-4·4) in women who initiated ART before pregnancy to 19·9% (13·4-28·6) in women not on ART. In multivariable logistic regression analysis, the odds of early MTCT were higher in mothers starting ART post partum (adjusted odds ratio 16·7, 95% CI 1·6-171·5; p=0·022) and in those not on ART with an unknown HIV status during pregnancy (19·1, 8·5-43·0; p<0·0001) than in mothers on ART before pregnancy. Among HIV-exposed infants, 98·0% (95% CI 96·9-99·1) were reported by the mother to have received infant nevirapine prophylaxis, and only 45·6% (34·8-56·4) were already enrolled in an exposed infant HIV care clinic at the time of study screening. INTERPRETATION: These data suggest that Malawi's decentralisation of ART services has resulted in higher ART coverage and lower early MTCT. However, the uptake of services for HIV-exposed infants remains suboptimal. FUNDING: President's Emergency Plan for AIDS Relief.