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

Human Immunodeficiency Virus Clinical Trial

— Periscope  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04143009
• Other study ID #: 19-1689
• Secondary ID: 5R34MH116806-02
• Status: Completed
• Phase: N/A
• Start date: December 10, 2019
• Est. completion date: August 31, 2022

Study information

• Verified date: August 2022
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: August 31, 2022
• Est. primary completion date: August 31, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Depression
• HIV Infections
• Human Immunodeficiency Virus
• Perinatal Depression

Intervention

Behavioral:
• Enhanced 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.

Other:
• Enhanced 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.

Behavioral:
• Adapted 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.

Locations

Country	Name	City	State
Malawi	Lumbadzi Health Center	Lilongwe
Malawi	Mitundu Health Center	Lilongwe	Lilogwe
Malawi	Nathenje Health Center	Lilongwe

Sponsors (5)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	Brown University, Ministry of Health, Malawi, National Institute of Mental Health (NIMH), University of Zimbabwe

Country where clinical trial is conducted

Malawi, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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).	6 months post-partum
Other	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.	6 months post-partum
Other	Proportion of Women Virally Suppressed	The proportion of women in each arm with an HIV viral load of <1,000 copies/mL	6 months post partum
Other	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	6 months post partum
Primary	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
Primary	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
Primary	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
Primary	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	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.	6 months post-partum