N/A
N=12
Adaptation of the Friendship Bench Intervention for HIV-infected Perinatal Women in Lilongwe
Human Immunodeficiency Virus · Perinatal Depression
Bottom Line
View on ClinicalTrials.gov: NCT04143009 ↗Enrolled (actual)
12
Serious AEs
10.9%
Results posted
Aug 2023
Primary outcome: Primary: Intervention Feasibility- Number of Participants Enrolled in Each Arm — 5; 43; 44 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Enhanced Friendship Bench (Behavioral); Enhanced Standard Care (Control) (Other); Adapted Friendship Bench (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of North Carolina, Chapel Hill
- Primary completion
- Aug 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Intervention Feasibility- Number of Participants Enrolled in Each Arm |
5; 43; 44 | — |
| PRIMARY Intervention Feasibility- Proportion of Women Retained in Each Study Arm at 6 Months Post-partum |
1; 0.98; 0.98 | — |
| PRIMARY Acceptability of Intervention- Proportion of Women Enrolled That Found Intervention Easy to Participate in |
1 | — |
| PRIMARY Fidelity to Intervention- Proportion of Observed Intervention Sessions Covering 80% of Intervention Checklist Items |
0.83 | — |
| SECONDARY Composite Outcome: Proportion of Women Retained in HIV Care With Improved Depression |
0.20; 0.40; 0.14 | — |
Summary
In many sub-Saharan African countries, the scale-up of lifelong antiretroviral treatment (ART) to all pregnant and breastfeeding women under Option B+ has the potential to radically improve maternal health and reduce mother-to-child HIV transmission. However, loss to HIV care after delivery has emerged as an important threat to the hoped-for impact of Option B+. Evidence suggests that one important contributor to postpartum loss to HIV care is perinatal depression (PND). In non-pregnant HIV-infected populations, depression has been linked to poor ART adherence, reduced engagement in care, and ultimately worse HIV clinical outcomes. Thus, interventions that integrate PND treatment with targeted support for HIV care retention are critical to the success of Option B+.
The Friendship Bench is an evidence-based depression counseling intervention delivered by trained, supervised lay health workers. It is proven to reduce depression in the general population in low-resource settings, but has not been adapted to address PND, or enhanced to support engagement in HIV care. The Friendship Bench offers an ideal framework for integrating retention support into a proven depression treatment model. Our long-term goal is to adapt, test, and scale up resource-appropriate interventions to reduce PND and improve engagement in HIV care. The objective of this proposal is to lay the groundwork for an effectiveness trial by adapting the Friendship Bench intervention to address PND and support engagement in care among perinatal HIV-infected women and assessing the feasibility, acceptability, and fidelity of the adapted intervention in Lilongwe, Malawi. In-depth perspectives on PND and its role in engagement in care will be gathered from HIV-infected women with PND, healthcare providers, clinic directors, and Ministry of Health officials using qualitative interviews and focus groups. This formative research will be used to develop an intervention protocol adapted to the unique needs of HIV-infected women during the perinatal period (Adapted Friendship Bench) and further enhanced to support engagement in HIV care (Enhanced Friendship Bench). The Adapted and Enhanced Friendship Bench interventions will be compared to enhanced standard care in a 3-arm pilot study. Feasibility, acceptability, and fidelity will be assessed at 6 months postpartum, along with the interventions' preliminary effectiveness across several mental health and engagement in HIV care measures.
Eligibility Criteria
Women
Inclusion criteria
- HIV-infected, pregnant women initiating or re-initiating ART during antenatal care (ANC)
- ≤30 weeks gestation to allow sufficient time for approximately 4 prenatal counseling sessions and approximately 2 postnatal counseling sessions.
- Screened positive for depression with a score > 8 on the Self-Reporting Questionnaire 20-item (SRQ-20)
- At least 18 years of age
Exclusion criteria
- Women already successfully established on ART will be excluded because they are at a lower risk for disengagement from HIV care.
Data sourced from ClinicalTrials.gov (NCT04143009). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.