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Clinical Trials/NCT04143009
NCT04143009
Completed
Not Applicable

Adaptation of the Friendship Bench Mental Health Intervention for HIV-infected Perinatal Women in Lilongwe (Periscope)

University of North Carolina, Chapel Hill3 sites in 1 country92 target enrollmentDecember 10, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Human Immunodeficiency Virus
Sponsor
University of North Carolina, Chapel Hill
Enrollment
92
Locations
3
Primary Endpoint
Intervention Feasibility- Proportion of Women Retained in Each Study Arm at 6 Months Post-partum
Status
Completed
Last Updated
2 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
December 10, 2019
End Date
August 31, 2022
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Intervention Feasibility- Proportion of Women Retained in Each Study Arm at 6 Months Post-partum

Time Frame: 6-months post-partum

The proportion of enrolled study participants that remain in their assigned study arm at 6-months post-partum.

Intervention Feasibility- Number of Participants Enrolled in Each Arm

Time Frame: Study enrollment period of approximately 16 months

This measure of feasibility will be assessed as the number of women enrolled in each arm out of the desired total sample size of 92 women during the 16 month recruitment period.

Acceptability of Intervention- Proportion of Women Enrolled That Found Intervention Easy to Participate in

Time Frame: 6 months post-partum

The proportion of women in the intervention arm (EFB) that were either "satisfied" or "highly satisfied" with the intervention as reported in the 6-month follow-up survey.

Fidelity to Intervention- Proportion of Observed Intervention Sessions Covering 80% of Intervention Checklist Items

Time Frame: Entire study period (Study baseline through 6 months post-partum)

Fidelity will be assessed by members of the Friendship Bench team (DHO or study psychiatrist), by using a checklist of intervention characteristics either during direct monitoring or using audio recording of up to 3 randomly chosen counseling sessions. Scoring either 'meeting expectations' or 'exceeding' expectations' on at least 80% of applicable checklist items during each session will be considered fidelity to the intervention protocol.

Secondary Outcomes

  • Composite Outcome: Proportion of Women Retained in HIV Care With Improved Depression(6 months post-partum)

Study Sites (3)

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