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An Intervention to Improve Mental Health and HIV Care Engagement Among Perinatal Women in Malawi: A Pilot Randomized Controlled Trial.

ABSTRACT: Perinatal depression (PND) is common and an important barrier to engagement in HIV care for women living with HIV (WLHIV). Accordingly, we adapted and enhanced The Friendship Bench, an evidence-based counseling intervention, for perinatal WLHIV. In a pilot randomized trial (NCT04143009), we evaluated the feasibility, acceptability, fidelity, and preliminary efficacy of the Enhanced Friendship Bench (EFB) intervention to improve PND and engagement in HIV care outcomes. Eighty pregnant WLHIV who screened positive for PND symptoms on the Self-Report Questionnaire (≥ 8) were enrolled, randomized 1:1 to EFB or usual care, and followed through 6 months postpartum. Overall, 100% of intervention participants were satisfied with the intervention and 93% found it beneficial to their overall health. Of 82 counseling sessions assessed for fidelity, 83% met or exceeded the fidelity threshold. At 6 months postpartum, intervention participants had improved depression remission (59% versus 36%, RD 23%, 95% CI 2%, 45%), retention in HIV care (82% versus 69%, RD 13%, -6%, 32%), and viral suppression (96% versus 90%, RD 7%, -7%, 20%) compared to usual care. Adverse events did not differ by arm. These results suggest that EFB intervention should be evaluated in a fully powered randomized trial to evaluate its efficacy to improve PND and engagement in HIV care outcomes for WLHIV.

SUBMITTER: Bengtson AM

PROVIDER: S-EPMC10119837 | biostudies-literature | 2023 Nov

REPOSITORIES: biostudies-literature

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An Intervention to Improve Mental Health and HIV Care Engagement Among Perinatal Women in Malawi: A Pilot Randomized Controlled Trial.

Bengtson Angela M AM Filipowicz Teresa R TR Mphonda Steven S Udedi Michael M Kulisewa Kazione K Meltzer-Brody Samantha S Gaynes Bradley N BN Go Vivian F VF Chibanda Dixon D Verhey Ruth R Hosseinipour Mina C MC Pence Brian Wells BW

AIDS and behavior 20230421 11

Perinatal depression (PND) is common and an important barrier to engagement in HIV care for women living with HIV (WLHIV). Accordingly, we adapted and enhanced The Friendship Bench, an evidence-based counseling intervention, for perinatal WLHIV. In a pilot randomized trial (NCT04143009), we evaluated the feasibility, acceptability, fidelity, and preliminary efficacy of the Enhanced Friendship Bench (EFB) intervention to improve PND and engagement in HIV care outcomes. Eighty pregnant WLHIV who s ...[more]

PMID: 37084104

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Project description:BackgroundAdolescents in Sub-Saharan Africa are disproportionately affected by the HIV epidemic. Comorbid depression is prevalent among adolescents living with HIV (ALWH) and poses numerous challenges to HIV care engagement and retainment. We present a pilot trial designed to investigate feasibility, fidelity, and acceptability of an adapted and an enhanced Friendship Bench intervention (henceforth: AFB and EFB) in reducing depression and improving engagement in HIV care among ALWH in Malawi.MethodsDesign: Participants will be randomized to one of three conditions: the Friendship Bench intervention adapted for ALWH (AFB, n = 35), the Friendship Bench intervention enhanced with peer support (EFB, n = 35), or standard of care (SOC, n = 35). Recruitment is planned for early 2024 in four clinics in Malawi. Participants: Eligibility criteria (1) aged 13-19; (2) diagnosed with HIV (vertically or horizontally); (3) scored ≥ 13 on the self-reported Beck's Depression Inventory (BDI-II); (4) living in the clinic's catchment area with intention to remain for at least 1 year; and (5) willing to provide informed consent. Interventions: AFB includes 6 counseling sessions facilitated by young, trained non-professional counselors. EFB consists of AFB plus integration of peer support group sessions to facilitate engagement in HIV care. SOC for mental health in public facilities in Malawi includes options for basic supportive counseling, medication, referral to mental health clinics or psychiatric units at tertiary care hospitals for more severe cases. Outcomes: The primary outcomes are feasibility, acceptability, and fidelity of the AFB and EFB assessed at 6 months and 12 months and compared across 3 arms. The secondary outcome is to assess preliminary effectiveness of the interventions in reducing depressive symptoms and improving HIV viral suppression at 6 months and 12 months.DiscussionThis pilot study will provide insights into youth-friendly adaptations of the Friendship Bench model for ALWH in Malawi and the value of adding group peer support for HIV care engagement. The information gathered in this study will lead to a R01 application to test our adapted intervention in a large-scale cluster randomized controlled trial to improve depression and engagement in HIV care among ALWH.Trial registrationClinicalTrials.gov (NCT06173544).

Project description:Sustained engagement in HIV care is critical to the success of Option B+ for HIV-infected pregnant women. However, monitoring women's engagement in care across clinics and over time is challenging due to migration and clinic transfers. Improved strategies to identify and monitor women's engagement in HIV care across a network of clinics are needed, but have not been pilot tested. We evaluated the feasibility and acceptability of biometric fingerprint scanning to identify women and monitor HIV visit attendance among women in Option B+. Over a 3-month period, we enrolled HIV-infected pregnant women receiving care at two antenatal clinics in Lilongwe, Malawi and monitored their engagement in care using biometric fingerprint scanning and the standard-of-care electronic medical record (EMR) monitoring system. Biometric data was collected by trained research assistants, who uploaded and synced data across study sites daily using wireless internet. We collected data weekly on the biometric scanner performance, reliability, and usability. We assessed the feasibility and acceptability of using biometric fingerprint scanning to record HIV visits during exit interviews with a sample of participants and healthcare workers and by comparing visit concordance between the biometric fingerprint scanning and EMR systems. We enrolled 314 HIV-infected pregnant women and 51 HCWs (n = 365 total participants). The majority of participants felt the biometric fingerprint scanning system was easy to use (64%), required no additional assistance (69%) and met their expectations (76%). No major issues with data security, privacy, or scanner functionality were reported by HIV-infected women or healthcare workers. Of the 542 HIV visits captured during the study period among women in Option B+, 80% were recorded in the biometric fingerprint system versus 51% in the EMR system (PR 1.57, 95% CI 1.43, 1.72, p-value < 0.05). Among HIV-infected pregnant women engaged in HIV care, biometric fingerprint scanning is a feasible and acceptable way to monitor HIV visits and may improve the ability to monitor women's engagement in HIV care over time and across clinics. Biometric fingerprint scanning should be scaled-up and evaluated as an implementation strategy to support sustained engagement in HIV care for women during the perinatal period.

Project description:IntroductionDisengagement from HIV care during the perinatal period remains a challenge. Improving engagement in HIV care requires monitoring engagement across multiple indicators, including retention in HIV care, visit adherence, clinic transfers, and viral suppression to support improved clinical and programmatic outcomes.MethodsWe enrolled a prospective cohort of pregnant WHIV across a network of five urban clinics in Lilongwe, Malawi from February 2020-February 2021. WHIV were followed from their first antenatal care visit through 9 months postpartum across all study sites using biometric fingerprint scanning. Study visits occurred at enrollment into antenatal care, 6 weeks', 6 months, and 9 months postpartum. In addition, all usual care HIV visits were captured via medical records. Participants who missed a study visit or usual care visit were traced. We evaluated determinants of multiple indicators of engagement in care, including retention in HIV care (attending a scheduled visit or self-reported recent visit when traced), HIV visit adherence (missed scheduled HIV visits and HIV visit coverage), clinic transfers, and viral load suppression (< 1000 copies/mL) using modified Poisson regression and sub-distributional hazard ratios to account for competing events of death and loss-to-follow-up. Associations between clinic transfer and subsequent indicators of engagement in HIV care were evaluated using generalized estimating equations.ResultsAmong 399 participants, 81% were on ART at baseline. Retention in HIV care was 87% at 6 weeks postpartum, 77% at 6 months postpartum and 89% at 9 months postpartum. At 9 months postpartum, 91% of participants were virally suppressed, 81% had missed a scheduled HIV visit, and 19% had transferred clinics. WHIV who transferred clinics were most likely to miss their subsequent scheduled HIV visit by ≥ 30 days. Transferring clinics was not associated with unsuppressed viral load or non-retention at 9 months postpartum.ConclusionsIn a cohort of WHIV, retention and viral load suppression were high in the perinatal period, but missed HIV visits and clinic transfers were common. Transferring clinics was associated with an increased likelihood of missing a subsequent HIV visit. Clinic transfers may be important indicators of disruptions in clinical care for WHIV in the perinatal period.

Project description:IntroductionAdvances in HIV treatment have proven to be effective in increasing virological suppression, thereby decreasing morbidity, and increasing survival. Medication adherence is an important factor in reducing viral load among people living with HIV (PLWH) and in the elimination of transmission of HIV to uninfected partners. Achieving optimal medication adherence involves individuals taking their medications every day or as prescribed by their provider. However, not all PLWH in the USA are engaged in care, and only a minority have achieved suppressed viral load (viral load that is lower than the detectable limit of the assay). Sexual and gender minorities (SGM; those who do not identify as heterosexual or those who do not identify as the sex they were assigned at birth) represent a high-risk population for poor clinical outcomes and increased risk of HIV transmission, as they face barriers that can prevent optimal engagement in HIV care. Research in dyadic support, specifically within primary romantic partnerships, offers a promising avenue to improving engagement in care and treatment outcomes among SGM couples. Dyadic interventions, especially focused on primary romantic partnerships, have the potential to have a sustained impact after the structured intervention ends.Methods and analysisThis paper describes the protocol for a randomised control trial of a theory-grounded, piloted intervention (DuoPACT) that cultivates and leverages the inherent sources of support within primary romantic relationships to improve engagement in HIV care and thus clinical outcomes among persons who are living with HIV and who identify as SGM (or their partners). Eligible participants must report being in a primary romantic relationship for at least 3 months, speak English, at least one partner must identify as a sexual or gender minority and at least one partner must be HIV+ with suboptimal engagement in HIV care, defined as less than excellent medication adherence, having not seen a provider in at least the past 8 months, having a detectable or unknown viral load or not currently on antiretroviral therapy. Eligible consenting couples are allocated equally to the two study arms: a structured six-session couples counselling intervention (DuoPACT) or a three-session individually-delivered HIV adherence counselling intervention (LifeSteps). The primary aim is to evaluate the efficacy of DuoPACT on virological suppression among HIV+ members of SGM couples with suboptimal engagement in care. The DuoPACT study began its target enrolment of 150 couples (300 individuals) in August 2017, and will continue to enrol until June 2021.Ethics and disseminationAll procedures are approved by the Institutional Review Board at the University of California, San Francisco. Written informed consent is obtained from all participants at enrolment, and study progress is reviewed twice yearly by an external Safety Monitoring Committee. Dissemination activities will include formal publications and report back sessions with the community.Trial registration numberNCT02925949; Pre-results.

Project description:ObjectiveSuicidal ideation is strikingly common among people living with HIV (PLWH) worldwide, leading to higher burden of disease, poor HIV care engagement, and loss of life. In low- and middle-income countries such as Tanzania, mental health resources are scarce, requiring innovative strategies for treatment. We describe the protocol for a clinical trial of a three-session telehealth counseling intervention to reduce suicidality and improve HIV care engagement in Tanzania.MethodsIn a pilot randomized controlled trial, we will assess the feasibility, acceptability, and potential efficacy of a new telehealth intervention, termed "IDEAS for Hope". A total of 60 PLWH will be enrolled from two HIV clinics in the Kilimanjaro region and connected to telehealth counsellors based at a large regional hospital. Participants will be ≥18 years old and speak either Kiswahili or English. Patient screening will occur during routine HIV clinical care to identify PLWH experiencing suicidal ideation. Baseline surveys will be administered upon enrollment and participants will be randomized 1:1 to receive either IDEAS for Hope or the comparison condition, a brief safety planning session. All participants will receive an additional referral for psychiatric treatment. Follow-up assessment will occur at three months. IDEAS for Hope is informed by a Motivational Interviewing-enhanced safety planning intervention (MI-SafeCope) and our formative work in Tanzania. The model consists of Four Pillars: living healthy with HIV, managing HIV stigma, seeking social support, and meeting basic needs. Together, these mechanisms serve as a foundation for developing a sense of safety and hope for the future. Outcome measures will include intervention feasibility, acceptability, participant suicidality, and HIV care engagement.SignificanceInnovative, telehealth-based counseling represents a promising treatment for suicidality among PLWH in low-resource settings. Results from this pilot trial will inform intervention refinement and parameter estimates for a future clinical trial powered to evaluate effectiveness.

Dataset Information

An Intervention to Improve Mental Health and HIV Care Engagement Among Perinatal Women in Malawi: A Pilot Randomized Controlled Trial.

Publications

An Intervention to Improve Mental Health and HIV Care Engagement Among Perinatal Women in Malawi: A Pilot Randomized Controlled Trial.

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