Adaptation of the Friendship Bench Intervention for HIV-infected Perinatal Women in Lilongwe

Not Applicable

Completed

• Conditions: Human Immunodeficiency Virus; Perinatal Depression
• Interventions: Behavioral: Enhanced Friendship Bench; Other: Enhanced Standard Care (Control); Behavioral: Adapted Friendship Bench

• Registration Number: NCT04143009
• Lead Sponsor: University of North Carolina, Chapel Hill

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-10-25
• Study First Submitted QC: 2019-10-25
• Study First Posted: 2019-10-29
• Study Start: 2019-12-10
• Status Verified: 2022-08
• Primary Completion: 2022-08-31
• Study Completion: 2022-08-31
• Results First Submitted: 2023-07-11
• Results First Submitted QC: 2023-08-10
• Last Update Submitted: 2023-08-10
• Results First Posted: 2023-08-14
• Last Update Posted: 2023-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 92

Inclusion Criteria

Not provided

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Enhanced Friendship Bench (EFB)	Enhanced Friendship Bench	Women seeking ANC services at 2 public health centers in Lilongwe, Malawi will be enrolled into this study arm during study recruitment. Individuals enrolled in this arm will be administered the Enhanced Friendship Bench intervention from date of enrollment through 6 months post-partum.
Enhanced Standard Care (ESC)	Enhanced Standard Care (Control)	Women seeking ANC services at 2 public health centers in Lilongwe, Malawi will be enrolled into this study arm during study recruitment. Individuals enrolled in this arm will received the Enhanced Standard Care intervention from date of enrollment through 6 months post-partum.
Adapted Friendship Bench (AFB)	Adapted Friendship Bench	Women seeking ANC services at 2 public health centers in Lilongwe, Malawi will be enrolled into this study arm during study recruitment. Individuals enrolled in this arm will be administered the Adapted Friendship Bench intervention from date of enrollment through 6 months post-partum.

Primary Outcome Measures

Name	Time	Method
Intervention Feasibility- Proportion of Women Retained in Each Study Arm at 6 Months Post-partum	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	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	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	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 Outcome Measures

Name	Time	Method
Composite Outcome: Proportion of Women Retained in HIV Care With Improved Depression	6 months post-partum	The investigator will assess a combined outcome at 6 months of whether a woman was retained in HIV care (defined as attending an HIV care appointment within the 30 days prior to the 6-month interview) and had ≥50% improvement in the Self-Reporting Questionnaire-20 (SRQ-20) score from baseline. The SRQ-20 was developed by the World Health Organization and has scores ranging from 0 to 20 and higher scores indicating a greater level of depression. Scores greater than or equal to 8 are typically considered indicative of a common mental disorder (CMD).; This measure will capture the proportion of enrolled women with the composite outcome of interest described above.

Trial Locations

Locations (3)

Lumbadzi Health Center; 🇲🇼 Lilongwe, Malawi

Nathenje Health Center; 🇲🇼 Lilongwe, Malawi

Mitundu Health Center; 🇲🇼 Lilongwe, Lilogwe, Malawi