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

NCT04143009 | Completed Results DMC

• 2 other identifiers: 19-16895R34MH116806-02
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 3

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.

Conditions

Human Immunodeficiency Virus; Perinatal Depression

Keywords

HIV; Depression

Outcome Measures

Primary Outcomes (4)

• Intervention Feasibility- Number of Participants Enrolled in Each Arm

  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.

  Study enrollment period of approximately 16 months

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

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

  6-months post-partum

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

  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.

  6 months post-partum

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

  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.

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

Secondary Outcomes (1)

• Composite Outcome: Proportion of Women Retained in HIV Care With Improved Depression

  6 months post-partum

Other Outcomes (4)

• Proportion of Women Reporting a Score Greater Than or Equal to 8 on the Self-Reporting Questionnaire-20 (SRQ-20)

  6 months post-partum

• Proportion of Women Retained in HIV Care

  6 months post-partum

• Proportion of Women Virally Suppressed

  6 months post partum

Study Arms (3)

Enhanced Friendship Bench (EFB)

EXPERIMENTAL

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.

Behavioral: Enhanced Friendship Bench

Enhanced Standard Care (ESC)

ACTIVE COMPARATOR

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.

Other: Enhanced Standard Care (Control)

Adapted Friendship Bench (AFB)

EXPERIMENTAL

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.

Behavioral: Adapted Friendship Bench

Interventions

Enhanced Friendship Bench BEHAVIORAL

EFB will include the following: integrating problem solving therapy- based ART adherence support into existing counseling sessions and providing opportunities for participants to address HIV-specific concerns, such as stigma, disclosure, mother-to-child HIV transmission or other issues women identify during counseling sessions, and retention strategies to support engagement in care for HIV-infected women with PND. This intervention will include 4 individual prenatal and 2 group postnatal counseling sessions. To provide additional social support, one support session will be added, at which participants will be invited to bring a person of her choice who can be a support to her in managing both her HIV and/or depression. To assist women with receiving their medication during late pregnancy and postpartum, a trained psychosocial counselor will conduct up to 6 home visits. At each home visit, counselors will be able to deliver a participants' medications and conduct a counseling session.

Enhanced Friendship Bench (EFB)

Enhanced Standard Care (Control) OTHER

Standard care for mental health in public facilities in Malawi includes options for basic supportive counseling by the primary provider or nurse, medication management by the primary provider, referral to the clinic psychiatric nurse or mental health clinic, or in more severe cases referral to the psychiatric units at tertiary care hospitals. For this study, standard care will be enhanced by a trained study research assistant who will provide mental health evaluation; brief supportive counseling; information, education, and support on common mental disorders; and (if indicated) facilitation of referral to the clinic's psychiatric nurse or mental health clinic. The study research assistant will have up to 3 follow-up contacts with the participant to assess whether she has followed up on recommended referrals or treatment plans and to assess whether any further outreach is indicated.

Enhanced Standard Care (ESC)

Adapted Friendship Bench BEHAVIORAL

Adapted Friendship Bench (AFB): AFB will include the following: integrating problem solving therapy- based and antiretroviral therapy (ART) adherence support into existing counseling sessions and providing opportunities for participants to address HIV-specific concerns, such as stigma, disclosure, mother-to-child HIV transmission or other issues women identify during counseling sessions. AFB will include 4 individual prenatal counseling session and 2 group postnatal counseling sessions. No specific retention support will be provided, but participants may identify barriers to engagement in HIV care to address during their pre- or postnatal counseling sessions.

Adapted Friendship Bench (AFB)

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: The investigators are recruiting pregnant women with perinatal depression
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Women already successfully established on ART will be excluded because they are at a lower risk for disengagement from HIV care.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Institute of Mental Health (NIMH): collaborator
• Brown University: collaborator
• Ministry of Health, Malawi: collaborator
• University of Zimbabwe: collaborator

Study Sites (3)

Mitundu Health Center

Lilongwe, Lilogwe, Malawi

Location

Lumbadzi Health Center

Lilongwe, Malawi

Location

Nathenje Health Center

Lilongwe, Malawi

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Depression

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Behavioral Symptoms; Behavior

Results Point of Contact

• Title: Brian Wells Pence, PhD
• Organization: University of North Carolina at Chapel Hill

bpence@unc.edu

+1 919-966-7446

Study Officials

• Brian Pence, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2019
• First Posted: October 29, 2019
• Study Start: December 10, 2019
• Primary Completion: August 31, 2022
• Study Completion: August 31, 2022
• Last Updated: August 14, 2023
• Results First Posted: August 14, 2023

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

MA (3)