Clinical trial NCT04143009: Adaptation of the Friendship Bench Intervention for HIV-infected Perinatal Women in Lilongwe
Official title: Adaptation of the Friendship Bench Mental Health Intervention for HIV-infected Perinatal Women in Lilongwe (Periscope)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Human Immunodeficiency Virus
Perinatal Depression
Keywords: HIV
Depression
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: Brown University
name: Ministry of Health, Malawi
name: University of Zimbabwe
First posted: 2019-10-29
Enrollment: 92
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility 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.

Primary outcomes:
measure: Intervention Feasibility- Number of Participants Enrolled in Each Arm
timeFrame: Study enrollment period of approximately 16 months
measure: Intervention Feasibility- Proportion of Women Retained in Each Study Arm at 6 Months Post-partum
timeFrame: 6-months post-partum
measure: Acceptability of Intervention- Proportion of Women Enrolled That Found Intervention Easy to Participate in
timeFrame: 6 months post-partum
measure: Fidelity to Intervention- Proportion of Observed Intervention Sessions Covering 80% of Intervention Checklist Items
timeFrame: Entire study period (Study baseline through 6 months post-partum)
Secondary outcomes:
measure: Composite Outcome: Proportion of Women Retained in HIV Care With Improved Depression
timeFrame: 6 months post-partum
Other outcomes:
measure: Proportion of Women Reporting a Score Greater Than or Equal to 8 on the Self-Reporting Questionnaire-20 (SRQ-20)
timeFrame: 6 months post-partum
measure: Proportion of Women Retained in HIV Care
timeFrame: 6 months post-partum
measure: Proportion of Women Virally Suppressed
timeFrame: 6 months post partum
measure: The Proportion of Women Whose Infants Received an HIV Viral Load Test
timeFrame: 6 months post partum
Locations:
city: Lilongwe
country: Malawi
facility: Mitundu Health Center
state: Lilogwe
city: Lilongwe
country: Malawi
facility: Lumbadzi Health Center
city: Lilongwe
country: Malawi
facility: Nathenje Health Center
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Brian Pence, PhD
role: PRINCIPAL_INVESTIGATOR
References: