An Economic and Relationship-strengthening Intervention for HIV-affected Couples Who Drink Alcohol in Malawi

HIV/AIDS Clinical Trial

Official title:

An Economic and Relationship-strengthening Intervention for HIV-affected Couples Who Drink Alcohol in Malawi

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04906616
• Other study ID #: P0535590
• Secondary ID: R34AA027983-01
• Status: Completed
• Phase: N/A
• Start date: May 31, 2021
• Est. completion date: July 13, 2023

Study information

• Verified date: January 2024
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A couples-based alcohol-reduction and economic and relationship-strengthening intervention for HIV-affected couples in Malawi.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 156
• Est. completion date: July 13, 2023
• Est. primary completion date: July 13, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Alcohol Abuse
• Alcoholism
• HIV/AIDS

Intervention

Behavioral:
• Mlambe
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.

Locations

Country	Name	City	State
Malawi	Invest in Knowledge Initiative (IKI)	Zomba

Sponsors (5)

Lead Sponsor	Collaborator
University of California, San Francisco	Invest in Knowledge Initiative (IKI) - Zomba, Malawi, National Institute on Alcohol Abuse and Alcoholism (NIAAA), University of Michigan, Washington University School of Medicine

Country where clinical trial is conducted

Malawi, 

References & Publications (6)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Exploratory: Alcohol Use	Number of drinking days in the past 21 days, assessed via the Timeline Follow-Back Method	10 months, 15 months
Other	Exploratory: Alcohol Use	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)	10 months, 15 months
Other	Exploratory: Viral Suppression	Proportion of HIV-infected participants who are virally suppressed by local lab normal ranges, as measured by dried blood spots (DBS)	10 months, 15 months
Other	Exploratory: ART Adherence	Proportion of pills taken by HIV-infected participants in the past 30 days, using the bean count method (self-report) adapted from VAS	10 months, 15 months
Primary	Enrollment Rate	Percentage of eligible couples enrolled in the study.	Baseline (Time 0)
Primary	Retention Rate	Percentage of enrolled and randomized participants retained at the end of the study	15 months
Secondary	Percentage of Couples Who Are "Satisfied" or "Very Satisfied" With the Intervention at 10 Months	Percentage of couples reporting to be "satisfied" or "very satisfied" about their overall experience with the Mlambe intervention on a five-point scale (the Mlambe Satisfaction Survey) at 10 months. Response options included: (1) very satisfied; (2) satisfied; (3) neutral; (4) unsatisfied; (5) very unsatisfied.	10 months
Secondary	Percentage of Couples Who Are Satisfied With the Intervention at 15 Months	Percentage of couples reporting to be "satisfied" or "very satisfied" about their overall experience with the Mlambe intervention on a five-point scale (the Mlambe Satisfaction Survey) at 15 months. Response options included: (1) very satisfied; (2) satisfied; (3) neutral; (4) unsatisfied; (5) very unsatisfied.	15 months
Secondary	10 Month Follow up Survey Completion	Percentage of couples who complete follow up surveys at 10 months	10 months
Secondary	15 Month Follow up Survey Completion	Percentage of couples who complete follow up surveys at 15 months	15 months
Secondary	75% Intervention Completion	Percentage of couples who attend 75% of intervention sessions	10 months
Secondary	100% Intervention Completion	Percentage of couples who attend 100% of intervention sessions	10 months