An Economic and Relationship-strengthening Intervention for HIV-affected Couples Who Drink Alcohol in Malawi
Primary Purpose
HIV/AIDS, Alcohol Abuse
Status
Active
Phase
Not Applicable
Locations
Malawi
Study Type
Interventional
Intervention
Mlambe
Sponsored by
About this trial
This is an interventional supportive care trial for HIV/AIDS
Eligibility Criteria
Inclusion Criteria:
- in a married or cohabitating union
- have at least one partner with a positive AUDIT-C screen in prior 3 months who is also currently on ART for at least 6 months who has disclosed their HIV status to their partner
Exclusion Criteria:
- severe intimate partner violence reported in previous 3 months and/or fear that safety would be at risk by participation in the study (reported at screening)
Sites / Locations
- Invest in Knowledge Initiative (IKI)
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control Comparison
Mlambe Intervention
Arm Description
Standard of care, e.g. regular HIV care plus brief advice on alcohol use
A couples-based intervention to reduce problematic drinking and improve economic and HIV outcomes.
Outcomes
Primary Outcome Measures
Enrollment Rate
Proportion of eligible couples who agree to participate in the study
Retention Rate
Proportion of enrolled couples retained at the end of the study
Secondary Outcome Measures
Proportion of couples who are satisfied with the intervention at 10 months
Proportion of couples reporting to be "satisfied" or "very satisfied" about their overall experience with the Mlambe intervention on a five-point Likert scale at 10 months.
Proportion of couples who are satisfied with the intervention at 15 months
Proportion of couples reporting to be "satisfied" or "very satisfied" about their overall experience with the Mlambe intervention on a five-point Likert scale at 15 months.
10 month follow up survey completion
Proportion of couples who complete follow up surveys at 10 months
15 month follow up survey completion
Proportion of couples who complete follow up surveys at 15 months
75% Intervention Completion
Proportion of couples who attend 75% of intervention sessions
100% Intervention Completion
Proportion of couples who attend 100% of intervention sessions
Full Information
NCT ID
NCT04906616
First Posted
May 25, 2021
Last Updated
September 18, 2023
Sponsor
University of California, San Francisco
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA), Invest in Knowledge Initiative (IKI) - Zomba, Malawi, University of Michigan, Washington University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT04906616
Brief Title
An Economic and Relationship-strengthening Intervention for HIV-affected Couples Who Drink Alcohol in Malawi
Official Title
An Economic and Relationship-strengthening Intervention for HIV-affected Couples Who Drink Alcohol in Malawi
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 31, 2021 (Actual)
Primary Completion Date
May 31, 2024 (Anticipated)
Study Completion Date
May 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA), Invest in Knowledge Initiative (IKI) - Zomba, Malawi, University of Michigan, Washington University School of Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
A couples-based alcohol-reduction and economic and relationship-strengthening intervention for HIV-affected couples in Malawi.
Detailed Description
This project aims to develop and pilot test a combined economic and relationship-strengthening intervention to redirect funds spent on alcohol into financial investments (e.g., education, income-generating business) and to improve couple relationships and adherence to ART. The study hypothesizes that engaging couples to work together on alcohol use and financial goals-equipped with financial, communication, and problem-solving skills-will decrease alcohol use, and improve relationship dynamics and adherence to ART. Specifically, the project aims: (1) to adapt and integrate two proven interventions, Suubi and Uthando Lwethu, using the ADAPT-ITT method, into a combined intervention for HIV-affected couples with a heavy alcohol user (to be called Mlambe); (2) to develop and pilot test the study procedures to evaluate Mlambe; and (3) to assess the feasibility and acceptability of Mlambe through a pilot study. In the formative phase, the study will develop a draft of the intervention manual and conduct five focus group discussions with couples and key stakeholders to obtain input on the intervention. In the pilot phase, 80 HIV-affected couples with a heavy alcohol user will be enrolled and randomized to either Mlambe or the comparison arm (regular HIV care plus brief advice on alcohol use). The study will conduct qualitative interviews with a subset of 20 couples to contextualize feasibility and acceptability data, and then will analyze the mixed- methods feasibility and acceptability data to refine intervention and procedures for a future trial.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV/AIDS, Alcohol Abuse
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Couples will be randomized 1:1 to intervention or control arm
Masking
None (Open Label)
Allocation
Randomized
Enrollment
156 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control Comparison
Arm Type
No Intervention
Arm Description
Standard of care, e.g. regular HIV care plus brief advice on alcohol use
Arm Title
Mlambe Intervention
Arm Type
Experimental
Arm Description
A couples-based intervention to reduce problematic drinking and improve economic and HIV outcomes.
Intervention Type
Behavioral
Intervention Name(s)
Mlambe
Intervention Description
A combined economic and relationship-strengthening intervention at the couple level to redirect funds spent on alcohol into financial investments (e.g., education, income-generating business) and to improve couple relationships and adherence to ART.
Primary Outcome Measure Information:
Title
Enrollment Rate
Description
Proportion of eligible couples who agree to participate in the study
Time Frame
Baseline (Time 0)
Title
Retention Rate
Description
Proportion of enrolled couples retained at the end of the study
Time Frame
15 months
Secondary Outcome Measure Information:
Title
Proportion of couples who are satisfied with the intervention at 10 months
Description
Proportion of couples reporting to be "satisfied" or "very satisfied" about their overall experience with the Mlambe intervention on a five-point Likert scale at 10 months.
Time Frame
10 months
Title
Proportion of couples who are satisfied with the intervention at 15 months
Description
Proportion of couples reporting to be "satisfied" or "very satisfied" about their overall experience with the Mlambe intervention on a five-point Likert scale at 15 months.
Time Frame
15 months
Title
10 month follow up survey completion
Description
Proportion of couples who complete follow up surveys at 10 months
Time Frame
10 months
Title
15 month follow up survey completion
Description
Proportion of couples who complete follow up surveys at 15 months
Time Frame
15 months
Title
75% Intervention Completion
Description
Proportion of couples who attend 75% of intervention sessions
Time Frame
10 months
Title
100% Intervention Completion
Description
Proportion of couples who attend 100% of intervention sessions
Time Frame
10 months
Other Pre-specified Outcome Measures:
Title
Exploratory: Alcohol use
Description
Number of drinking days in the past 21 days, assessed via the Timeline Follow-Back Method
Time Frame
10 months, 15 months
Title
Exploratory: Alcohol use
Description
Non-heavy drinking determined by self-report (Alcohol Use Disorders Identification Test - Consumption [AUDIT-C], prior 3 months, negative) and phosphatidylethanol (PEth) <35 ng/mL (composite measure)
Time Frame
10 months, 15 months
Title
Exploratory: viral suppression
Description
Proportion of HIV-infected participants who are virally suppressed by local lab normal ranges, as measured by dried blood spots (DBS)
Time Frame
10 months, 15 months
Title
Exploratory: ART adherence
Description
Proportion of pills taken by HIV-infected participants in the past 30 days, using the bean count method (self-report) adapted from VAS
Time Frame
10 months, 15 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
in a married or cohabitating union
have at least one partner with a positive AUDIT-C screen in prior 3 months who is also currently on ART for at least 6 months who has disclosed their HIV status to their partner
Exclusion Criteria:
severe intimate partner violence reported in previous 3 months and/or fear that safety would be at risk by participation in the study (reported at screening)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amy Conroy, PhD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
Invest in Knowledge Initiative (IKI)
City
Zomba
Country
Malawi
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
28398134
Citation
Conroy A, Leddy A, Johnson M, Ngubane T, van Rooyen H, Darbes L. 'I told her this is your life': relationship dynamics, partner support and adherence to antiretroviral therapy among South African couples. Cult Health Sex. 2017 Nov;19(11):1239-1253. doi: 10.1080/13691058.2017.1309460. Epub 2017 Apr 11.
Results Reference
background
PubMed Identifier
30218319
Citation
Conroy AA, McKenna SA, Ruark A. Couple Interdependence Impacts Alcohol Use and Adherence to Antiretroviral Therapy in Malawi. AIDS Behav. 2019 Jan;23(1):201-210. doi: 10.1007/s10461-018-2275-2.
Results Reference
background
PubMed Identifier
31456201
Citation
Conroy AA, Ruark A, McKenna SA, Tan JY, Darbes LA, Hahn JA, Mkandawire J. The Unaddressed Needs of Alcohol-Using Couples on Antiretroviral Therapy in Malawi: Formative Research on Multilevel Interventions. AIDS Behav. 2020 Jun;24(6):1599-1611. doi: 10.1007/s10461-019-02653-y.
Results Reference
background
PubMed Identifier
30730356
Citation
Darbes LA, McGrath NM, Hosegood V, Johnson MO, Fritz K, Ngubane T, van Rooyen H. Results of a Couples-Based Randomized Controlled Trial Aimed to Increase Testing for HIV. J Acquir Immune Defic Syndr. 2019 Apr 1;80(4):404-413. doi: 10.1097/QAI.0000000000001948.
Results Reference
background
PubMed Identifier
19520472
Citation
Ssewamala FM, Han CK, Neilands TB. Asset ownership and health and mental health functioning among AIDS-orphaned adolescents: findings from a randomized clinical trial in rural Uganda. Soc Sci Med. 2009 Jul;69(2):191-8. doi: 10.1016/j.socscimed.2009.05.019. Epub 2009 Jun 10.
Results Reference
background
PubMed Identifier
29846836
Citation
Bermudez LG, Ssewamala FM, Neilands TB, Lu L, Jennings L, Nakigozi G, Mellins CA, McKay M, Mukasa M. Does Economic Strengthening Improve Viral Suppression Among Adolescents Living with HIV? Results From a Cluster Randomized Trial in Uganda. AIDS Behav. 2018 Nov;22(11):3763-3772. doi: 10.1007/s10461-018-2173-7.
Results Reference
background
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An Economic and Relationship-strengthening Intervention for HIV-affected Couples Who Drink Alcohol in Malawi
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