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

University of North Carolina (UNC)

Status: Completed

Conditions: Perinatal Depression; Human Immunodeficiency Virus

Treatments: Behavioral: Enhanced Friendship Bench; Other: Enhanced Standard Care (Control); Behavioral: Adapted Friendship Bench

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04143009

19-1689

5R34MH116806-02 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 92 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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92 participants in 3 patient groups

Enhanced Friendship Bench (EFB)

Experimental group

Description:

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.

Treatment:

Behavioral: Enhanced Friendship Bench

Enhanced Standard Care (ESC)

Active Comparator group

Description:

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.

Treatment:

Other: Enhanced Standard Care (Control)

Adapted Friendship Bench (AFB)

Experimental group

Description:

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.

Treatment:

Behavioral: Adapted Friendship Bench