NCT04143009: Periscope

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

Completed NA Results posted Last updated 14 August 2023

What this trial tests

NA trial testing Enhanced Friendship Bench in Human Immunodeficiency Virus in 92 participants. Completed in 31 August 2022.

Timeline

10 December 2019

Primary endpoint
31 August 2022

31 August 2022

Quick facts

Lead sponsor	University of North Carolina, Chapel Hill
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	other
Enrollment	92
Start date	10 December 2019
Primary completion	31 August 2022
Estimated completion	31 August 2022
Sites	3 locations across Malawi

Drugs / interventions tested

• Enhanced Friendship Bench
• Enhanced Standard Care (Control)
• Adapted Friendship Bench

Conditions studied

• Human Immunodeficiency Virus — all drugs for Human Immunodeficiency Virus →
• Perinatal Depression — all drugs for Perinatal Depression →

Sponsor

University of North Carolina, Chapel Hill

Who can join

18 and older, female only, with Human Immunodeficiency Virus or Perinatal Depression. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Intervention Feasibility- Number of Participants Enrolled in Each Arm Primary · Study enrollment period of approximately 16 months

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.

Group	Value	95% CI
Adapted Friendship Bench (AFB)	5
Enhanced Friendship Bench (EFB)	43
Enhanced Standard Care (ESC)	44

Intervention Feasibility- Proportion of Women Retained in Each Study Arm at 6 Months Post-partum Primary · 6-months post-partum

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

Group	Value	95% CI
Adapted Friendship Bench (AFB)	1
Enhanced Friendship Bench (EFB)	0.98
Enhanced Standard Care (ESC)	0.98

Acceptability of Intervention- Proportion of Women Enrolled That Found Intervention Easy to Participate in Primary · 6 months post-partum

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.

Group	Value	95% CI
Enhanced Friendship Bench (EFB)	1

Fidelity to Intervention- Proportion of Observed Intervention Sessions Covering 80% of Intervention Checklist Items Primary · Entire study period (Study baseline through 6 months post-partum)

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.

Group	Value	95% CI
Enhanced Friendship Bench (EFB)	0.83

Composite Outcome: Proportion of Women Retained in HIV Care With Improved Depression Secondary · 6 months post-partum

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 e

Group	Value	95% CI
Adapted Friendship Bench (AFB)	0.20
Enhanced Friendship Bench (EFB)	0.40
Enhanced Standard Care (ESC)	0.14

Proportion of Women Reporting a Score Greater Than or Equal to 8 on the Self-Reporting Questionnaire-20 (SRQ-20) Secondary · 6 months post-partum

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).

Group	Value	95% CI
Adapted Friendship Bench (AFB)	0.60
Enhanced Friendship Bench (EFB)	0.21
Enhanced Standard Care (ESC)	0.30

Proportion of Women Retained in HIV Care Secondary · 6 months post-partum

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

Group	Value	95% CI
Adapted Friendship Bench (AFB)	0.20
Enhanced Friendship Bench (EFB)	0.50
Enhanced Standard Care (ESC)	0.26

Proportion of Women Virally Suppressed Secondary · 6 months post partum

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

Group	Value	95% CI
Adapted Friendship Bench (AFB)	0.8
Enhanced Friendship Bench (EFB)	0.93
Enhanced Standard Care (ESC)	0.91

The Proportion of Women Whose Infants Received an HIV Viral Load Test Secondary · 6 months post partum

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

Group	Value	95% CI
Adapted Friendship Bench (AFB)	1
Enhanced Friendship Bench (EFB)	0.95
Enhanced Standard Care (ESC)	0.95

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events were collected from consent through each participant's study completion, up to approximately 6 months post-delivery.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Adapted Friendship Bench (AFB)

Serious: 1/5 (20%)

Deaths: 0/5

Enhanced Friendship Bench (EFB)

Serious: 4/43 (9%)

Deaths: 0/43

Enhanced Standard Care (ESC)

Serious: 5/44 (11%)

Deaths: 0/44

Serious adverse events (3 terms)

Reaction	System	Adapted Friendship Bench (…	Enhanced Friendship Bench …	Enhanced Standard Care (ESC)
Infant Death	Pregnancy, puerperium and perinatal conditions	—	—	—
Stillbirth	Pregnancy, puerperium and perinatal conditions	—	—	—
Miscarriage	Pregnancy, puerperium and perinatal conditions	—	—	—

Most-reported serious reactions: Infant Death, Stillbirth, Miscarriage.

Data from ClinicalTrials.gov NCT04143009 adverse events section.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Primary-level worker interventions for the care of people living with mental disorders and distress in low- and middle-income countries.
   van Ginneken N, Chin WY, Lim YC, Ussif A, et al · · 2021 · cited 89× · PMID 34352116 · DOI 10.1002/14651858.cd009149.pub3
2. An Intervention to Improve Mental Health and HIV Care Engagement Among Perinatal Women in Malawi: A Pilot Randomized Controlled Trial.
   Bengtson AM, Filipowicz TR, Mphonda S, Udedi M, et al · · 2023 · cited 14× · PMID 37084104 · DOI 10.1007/s10461-023-04070-8