Clinical trial NCT04906616: 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
Overall status: COMPLETED
Phase: NA
Conditions: HIV/AIDS
Alcohol Abuse
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
name: Invest in Knowledge Initiative (IKI) - Zomba, Malawi
name: University of Michigan
name: Washington University School of Medicine
First posted: 2021-05-28
Enrollment: 156
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Couples will be randomized 1:1 to intervention or control arm
Primary purpose: SUPPORTIVE_CARE

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.

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)

Primary outcomes:
measure: Enrollment Rate
timeFrame: Baseline (Time 0)
measure: Retention Rate
timeFrame: 15 months
Secondary outcomes:
measure: Percentage of Couples Who Are "Satisfied" or "Very Satisfied" With the Intervention at 10 Months
timeFrame: 10 months
measure: Percentage of Couples Who Are Satisfied With the Intervention at 15 Months
timeFrame: 15 months
measure: 10 Month Follow up Survey Completion
timeFrame: 10 months
measure: 15 Month Follow up Survey Completion
timeFrame: 15 months
measure: 75% Intervention Completion
timeFrame: 10 months
measure: 100% Intervention Completion
timeFrame: 10 months
Other outcomes:
measure: Exploratory: Alcohol Use
timeFrame: 10 months, 15 months
measure: Exploratory: Alcohol Use
timeFrame: 10 months, 15 months
measure: Exploratory: Viral Suppression
timeFrame: 10 months, 15 months
measure: Exploratory: ART Adherence
timeFrame: 10 months, 15 months
Locations:
city: Zomba
country: Malawi
facility: Invest in Knowledge Initiative (IKI)
Study officials:
affiliation: University of California, San Francisco
name: Amy Conroy, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.