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

Browse trials for

• Acquired Immunodeficiency Syndrome 2,099
• Depression 8,240

Keywords

• HIV
• Depression

Acquired Immunodeficiency Syndrome

2,099 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 273 are open to participants now.

This study's enrollment of 92 is below the median of 104 across 1,590 interventional studies indexed under Acquired Immunodeficiency Syndrome.

Lead sponsor

University of North Carolina, Chapel Hill is the lead sponsor of 1,366 studies on the registry; 133 are open to participants now.

Of its 158 completed or terminated interventional studies of FDA-regulated products, 139 (88%) have results posted.

Study arms

• Experimental
  Enhanced Friendship Bench (EFB)

  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

• Active comparator
  Enhanced Standard Care (ESC)

  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)

• Experimental
  Adapted Friendship Bench (AFB)

  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

• BehavioralEnhanced Friendship Bench

  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.

• OtherEnhanced Standard Care (Control)

  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.

• BehavioralAdapted Friendship Bench

  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.

Primary outcomes

1. 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.

   Time frame: Study enrollment period of approximately 16 months

2. 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.

   Time frame: 6-months post-partum

3. 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.

   Time frame: 6 months post-partum

4. 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.

   Time frame: 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

   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.

   Time frame: 6 months post-partum

Other outcomes

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

   The proportion of women in each arm that score greater than or equal to 8 on the Self-Reporting Questionnaire-20 at a study visit approximately 6-months post-partum. 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).

   Time frame: 6 months post-partum

2. Proportion of Women Retained in HIV Care

   The proportion of women who attended at least 1 HIV care appointment within 30-days prior to the 6-month interview.

   Time frame: 6 months post-partum

3. Proportion of Women Virally Suppressed

   The proportion of women in each arm with an HIV viral load of \<1,000 copies/mL

   Time frame: 6 months post partum

4. The Proportion of Women Whose Infants Received an HIV Viral Load Test

   The proportion of women in each arm whose infants had received an HIV viral load test by the time of a study visit approximately 6-months post-partum

   Time frame: 6 months post partum

Baseline characteristics

Study documents

• Protocol and statistical analysis plan · Dec 16, 2022
• Informed consent form · Nov 24, 2020

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No — The investigators do not intend to share individual participant data (IPD) with other researchers.