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

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ClinicalTrials.gov Identifier: NCT04143009
Recruitment Status : Recruiting
First Posted : October 29, 2019
Last Update Posted : January 10, 2020
Sponsor:
Collaborators:
National Institute of Mental Health (NIMH)
Brown University
Ministry of Health, Malawi
University of Zimbabwe
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

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.


Condition or disease Intervention/treatment Phase
Human Immunodeficiency Virus Perinatal Depression Behavioral: Adapted Friendship Bench Behavioral: Enhanced Friendship Bench Other: Enhanced Standard Care (Control) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 105 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Adaptation of the Friendship Bench Mental Health Intervention for HIV-infected Perinatal Women in Lilongwe (Periscope)
Actual Study Start Date : December 10, 2019
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Adapted Friendship Bench (AFB)
35 women seeking ANC services at Mitundu Clinic 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
In the AFB intervention, the existing Friendship Bench intervention protocol will be adapted to address the unique needs of HIV-infected women. This will include 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. 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.

Experimental: Enhanced Friendship Bench (EFB)
35 women seeking ANC services at Lumbadzi Clinic 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
EFB will include all elements of AFB, but will additionally integrate retention strategies to support engagement in care for HIV-infected women with PND. To provide additional social support for participants, one support session will be added to the AFB 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 also conduct up to six home visits in the EFB arm. At each home visit, counselors will be able to deliver a participants' medications and conduct a counseling session.

Active Comparator: Enhanced Standard Care (ESC)
35 women seeking ANC services at Nathenje Clinic 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)
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.




Primary Outcome Measures :
  1. Intervention Feasibility- Proportion of desired sample size met [ Time Frame: Study enrollment period of approximately 6 months ]
    This measure of feasibility will be assessed as the proportion of women enrolled in each arm out of the desired sample size of 35 women per arm during the six month recruitment period.

  2. Intervention Feasibility- Proportion of women retained in each study arm at 6 months post-partum [ Time Frame: 6-months post-partum ]
    The proportion of enrolled study participants that remain in their assigned study arm at 6-months post-partum.

  3. Acceptability of intervention- Proportion of women enrolled that found intervention easy to participate in [ Time Frame: 6 months post-partum ]
    The proportion of women in each arm that found their assigned intervention arm easy to adhere to as reported in participant exit interviews.

  4. Acceptability of intervention-Proportion of study staff that found intervention easy to deliver [ Time Frame: End of study trial (approximately 6 months post-partum of last enrolled participant) ]
    The proportion of study staff members that found the intervention easy to deliver as reported in staff exit interviews.

  5. Acceptability of intervention-Qualitative measure of perceived usefulness of intervention [ Time Frame: 6 months post-partum ]
    Qualitative summary of participant and provider responses to open-ended questions regarding usefulness of each intervention.

  6. Fidelity to intervention- Proportion of observed intervention sessions covering 80% of intervention checklist items [ Time Frame: 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 sessions per counselors. Covering at least 80% of checklist items during each session will be considered fidelity to the intervention protocol. This measure will capture the proportion of observed intervention sessions that cover 80% of the intervention checklist items.


Secondary Outcome Measures :
  1. Composite outcome: proportion of women retained in HIV care, virally suppressed, with improved depression. [ Time Frame: 6 months post-partum ]

    The investigator will assess a combined outcome at 6 months of whether a woman attended an HIV visit within the last 30 days, was virally suppressed (HIV RNA <1000 copies), 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.



Other Outcome Measures:
  1. Proportion of women reporting a score greater than or equal to 8 on the Self-Reporting Questionnaire-20 (SRQ-20) [ Time Frame: 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).

  2. Proportion of women retained in HIV Care [ Time Frame: 6 months post-partum ]
    The proportion of women who attended an HIV care visit in the last 30 days at a study visit approximately 6-months post-partum.

  3. Proportion of kept visits through 6 months post-partum [ Time Frame: Entire study period (study enrollment through 6 months post-partum) ]
    The proportion of scheduled visits that were kept in by women in each study arm.

  4. Proportion of women virally suppressed [ Time Frame: 6 months post partum ]
    The proportion of women in each arm with an HIV viral load of <1,000 copies/mL

  5. The proportion of women whose infants received an HIV viral load test [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   The investigators are recruiting pregnant women with perinatal depression
Accepts Healthy Volunteers:   No
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 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04143009


Contacts
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Contact: Steven Mphonda +265999272759 smphonda@unclilongwe.org

Locations
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Malawi
Mitundu Health Center Recruiting
Lilongwe, Lilogwe, Malawi
Contact: Steven Mphonda    +265999272759    smphonda@unclilongwe.org   
Lumbadzi Health Center Recruiting
Lilongwe, Malawi
Contact: Steven Mphonda    +265999272759    smphonda@unclilongwe.org   
Nathenje Health Center Recruiting
Lilongwe, Malawi
Contact: Steven Mphonda    +265999272759    smphonda@unclilongwe.org   
Sponsors and Collaborators
University of North Carolina, Chapel Hill
National Institute of Mental Health (NIMH)
Brown University
Ministry of Health, Malawi
University of Zimbabwe
Investigators
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Principal Investigator: Brian Pence, PhD University of North Carolina, Chapel Hill

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Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT04143009    
Other Study ID Numbers: 19-1689
5R34MH116806-02 ( U.S. NIH Grant/Contract )
First Posted: October 29, 2019    Key Record Dates
Last Update Posted: January 10, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The investigators do not intend to share individual participant data (IPD) with other researchers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of North Carolina, Chapel Hill:
HIV
Depression
Additional relevant MeSH terms:
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Acquired Immunodeficiency Syndrome
HIV Infections
Depression
Behavioral Symptoms
Immunologic Deficiency Syndromes
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases