Human Immunodeficiency VirusPeriscopeNCT04143009
Adaptation of the Friendship Bench Intervention for HIV-infected Perinatal Women in Lilongwe
A study testing Enhanced Friendship Bench and Adapted Friendship Bench in people with Human Immunodeficiency Virus and Perinatal Depression, run by University of North Carolina, Chapel Hill at 3 sites in Malawi.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Human Immunodeficiency Virus, Perinatal Depression
- What is being tested?
- Enhanced Friendship Bench and Adapted Friendship Bench
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 3 sitesMalawi
- Study dates
- 10 Dec 2019to 31 Aug 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Women already successfully established on ART will be excluded because they are at a lower risk for disengagement from HIV care.
Trial locations and contacts
3 sites in 1 country.
Malawi3 sites
Mitundu Health Center
Lilongwe, Lilogwe
Lumbadzi Health Center
Lilongwe
Nathenje Health Center
Lilongwe
About this study
Official title: Adaptation of the Friendship Bench Mental Health Intervention for HIV-infected Perinatal Women in Lilongwe (Periscope)
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.
- Conditions
- Human Immunodeficiency Virus, Perinatal Depression
- Being tested
- Enhanced Friendship Bench, Enhanced Standard Care (Control), Adapted Friendship Bench
- Keywords
- HIV, Depression
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced Friendship BenchBehavioural
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.
Enhanced Standard Care (Control)Other
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.
Adapted Friendship BenchBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Enhanced Friendship Bench (EFB) | Experimental | 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. Receives: Behavioral: Enhanced Friendship Bench |
| Enhanced Standard Care (ESC) | Active comparator | 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. Receives: Other: Enhanced Standard Care (Control) |
| Adapted Friendship Bench (AFB) | Experimental | 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. Receives: Behavioral: Adapted Friendship Bench |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Study enrollment period of approximately 16 months
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.
Measured: 6-months post-partum
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.
Measured: 6 months post-partum
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.
Measured: 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.
Measured: 6 months post-partum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2019
- Study start10 Dec 2019
- Primary completion31 Aug 2022
- Study completion31 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Human Immunodeficiency VirusStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Brown University, Ministry of Health, Malawi, University of Zimbabwe
- Responsible party
- Sponsor
- Investigators
- Brian Pence, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04143009
- Sponsor's protocol ID
- 19-1689
- Other IDs
- 5R34MH116806-02
- Acronym
- Periscope
- Status last verified
- Aug 2022
- First submitted
- 25 Oct 2019
- Last updated
- 14 Aug 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The investigators do not intend to share individual participant data (IPD) with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptation of the Friendship Bench Mental Health Intervention for HIV-infected Perinatal Women in Lilongwe (Periscope)
- ClinicalTrials.gov ID
- NCT04143009
- Acronym / sponsor ID
- Periscope / 19-1689
- Conditions
- Human Immunodeficiency Virus, Perinatal Depression
- Keywords
- HIV, Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Brown University, Ministry of Health, Malawi, University of Zimbabwe
- Study start
- 10 Dec 2019 (actual)
- Primary completion
- 31 Aug 2022 (actual)
- Study completion
- 31 Aug 2022 (actual)
- First posted
- 29 Oct 2019 (actual)
- Results
- Posted 14 Aug 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Enhanced Friendship Bench (EFB) | Experimental | Behavioral: Enhanced Friendship BenchWomen 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. |
| Enhanced Standard Care (ESC) | Active comparator | Other: Enhanced Standard Care (Control)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. |
| Adapted Friendship Bench (AFB) | Experimental | Behavioral: Adapted Friendship BenchWomen 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Women already successfully established on ART will be excluded because they are at a lower risk for disengagement from HIV care.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enhanced Friendship BenchEFB 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. | Behavioural | Enhanced Friendship Bench (EFB) |
| 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. | Other | Enhanced Standard Care (ESC) |
| Adapted Friendship BenchAdapted 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. | Behavioural | Adapted Friendship Bench (AFB) |
Primary outcome
Intervention Feasibility- Number of Participants Enrolled in Each Arm
Time frame: 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.
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.
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 the intervention arm (EFB) that were either "satisfied" or "highly satisfied" with the intervention as reported in the 6-month follow-up survey.
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 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.
1 secondary outcome
Composite Outcome: Proportion of Women Retained in HIV Care With Improved Depression
Time frame: 6 months post-partum
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. The investigators do not intend to share individual participant data (IPD) with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian Pence, PhD principal investigator
University of North Carolina, Chapel Hill
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced Friendship Bench and Adapted Friendship Bench in people with Human Immunodeficiency Virus and Perinatal Depression, run by University of North Carolina, Chapel Hill at 3 sites in Malawi.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Malawi. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intervention Feasibility- Number of Participants Enrolled in Each Arm (time frame: Study enrollment period of approximately 16 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2023.