Clinical trial NCT06367348: An Economic and Relationship-strengthening Intervention to Reduce Alcohol Use in Malawi
Official title: Mlambe: A Randomized Controlled Trial of an Economic and Relationship-Strengthening Intervention to Reduce Alcohol Use in Malawi
Study type: INTERVENTIONAL
Overall status: RECRUITING
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)
First posted: 2024-04-16
Enrollment: 500
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: With a full-scale randomized control trial, the investigators will evaluate the efficacy and cost effectiveness of Mlambe, an economic and relationship-strengthening intervention that provides incentivized saving accounts, financial literacy training, and relationship skills education to break the cycle of poverty around drinking, strengthen couple support and communication, and reduce heavy drinking among HIV-affected married couples with a partner who drinks alcohol in Malawi.

Detailed description: The inter-related issues of alcohol use, intimate partner violence (IPV), and economic insecurity threaten to derail progress towards UNAIDS 95-95-95 targets in sub-Saharan Africa (SSA). Rates of heavy drinking are alarmingly high among people living with HIV (PLWH), and almost twice that of the general population. Heavy drinking is very common in Malawi, and has deleterious effects on antiretroviral therapy (ART) adherence and HIV clinical outcomes, but also indirectly affects health by damaging the couple relationships needed for social support, economic survival, and well-being. Most alcohol interventions treat heavy drinking as an individual-level issue; however, for people in committed relationships, research suggests an urgent need for interventions that consider alcohol use as a couple-level issue involving both partners. Novel alcohol interventions are paramount for breaking cycles of IPV and poverty, and creating stronger families to prevent HIV, and reduce HIV mortality, morbidity, and transmission. Yet, no interventions to date have jointly addressed the economic and relationship context of drinking alcohol among people living with HIV in SSA, which may have synergistic effects on heavy alcohol use when combined.

To address this gap, the investigators developed and tested Mlambe, an economic and relationship-strengthening intervention that provides incentivized saving accounts, financial literacy training, and relationship skills education to break the cycle of poverty around drinking, strengthen couple support and communication, and reduce heavy drinking. Pilot results showed that Mlambe was feasible and acceptable, and showed promise of efficacy. Given this strong evidence, the investigators will evaluate the efficacy and cost-effectiveness of Mlambe with a full-scale RCT. This is the first RCT of an integrated economic and relationship-strengthening intervention to address alcohol use in HIV-affected couples.

For Aim 1, the primary hypothesis is that the odds of heavy alcohol use will be lower in Mlambe as compared to enhanced usual care (EUC). Secondarily, the investigators expect that Mlambe participants will have a higher odds of ART and appointment adherence, and viral suppression, and lower number of drinking days, AUDIT-C score, and PEth levels. For Aim 2, the investigators hypothesize that Mlambe participants will report greater improvements in relationship dynamics (e.g., better communication, less IPV) as compared to EUC participants.

Eligibility criteria: Inclusion Criteria:

1. In a married or cohabitating union
2. Have at least one partner with a positive AUDIT-C screen in prior 3 months
3. Must also currently be on ART for at least 6 months
4. Must have disclosed their HIV status to their partner

Exclusion Criteria:

1) 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). Couples who participated in Mlambe's pilot study will also be excluded.

Primary outcomes:
measure: Unhealthy alcohol use measured using the Alcohol Use Disorders Identification Test (AUDIT-C) and/or the Phosphatidylethanol test
timeFrame: 11 months
measure: Unhealthy alcohol use measured using the Alcohol Use Disorders Identification Test (AUDIT-C) and/or the Phosphatidylethanol test
timeFrame: 15 months
measure: Unhealthy alcohol use measured using the Alcohol Use Disorders Identification Test (AUDIT-C) and/or the Phosphatidylethanol test
timeFrame: 20 months
Secondary outcomes:
measure: Viral Suppression measured using whole blood viral load tests
timeFrame: 15 months
measure: Antiretroviral medication adherence measured using a Visual Analog Scale
timeFrame: 11 months
measure: Antiretroviral medication adherence measured using a Visual Analog Scale
timeFrame: 15 months
measure: Antiretroviral medication adherence measured using a Visual Analog Scale
timeFrame: 20 months
measure: Medical appointment adherence assessment
timeFrame: 11 months
measure: Medical appointment adherence assessment
timeFrame: 15 months
measure: Medical appointment adherence assessment
timeFrame: 20 months
measure: Number of drinking days measured using the "Timeline follow-back" method
timeFrame: 11 months
measure: Number of drinking days measured using the "Timeline follow-back" method
timeFrame: 15 months
measure: Number of drinking days measured using the "Timeline follow-back" method
timeFrame: 20 months
measure: AUDIT-C score measured using the Alcohol Use Disorders Identification Test.
timeFrame: 11 months
measure: AUDIT-C score measured using the Alcohol Use Disorders Identification Test.
timeFrame: 15 months
measure: AUDIT-C score measured using the Alcohol Use Disorders Identification Test.
timeFrame: 20 months
measure: PEth level measured using a Phosphatidylethanol biomarker test
timeFrame: 11 months
measure: PEth level measured using a Phosphatidylethanol biomarker test
timeFrame: 15 months
measure: PEth level measured using a Phosphatidylethanol biomarker test
timeFrame: 20 months
Other outcomes:
measure: Exploratory: Constructive Couple Communication measured using the mutually constructive communication subscale of the Communication Patterns Questionnaire.
timeFrame: 11 months
measure: Exploratory: Constructive Couple Communication measured using the mutually constructive communication subscale of the Communication Patterns Questionnaire.
timeFrame: 15 months
measure: Exploratory: Constructive Couple Communication measured using the mutually constructive communication subscale of the Communication Patterns Questionnaire.
timeFrame: 20 months
measure: Measuring alcohol-specific partner support using a measure adapted from the HIV-specific Partner Support Scale.
timeFrame: 11 months
measure: Measuring alcohol-specific partner support using a measure adapted from the HIV-specific Partner Support Scale.
timeFrame: 15 months
measure: Measuring alcohol-specific partner support using a measure adapted from the HIV-specific Partner Support Scale.
timeFrame: 20 months
measure: Exploratory: Assess the effects of Mlambe on Intimate Partner Violence (IPV)
timeFrame: 11 months
measure: Exploratory: Assess the effects of Mlambe on Intimate Partner Violence (IPV)
timeFrame: 15 months
measure: Exploratory: Assess the effects of Mlambe on Intimate Partner Violence (IPV)
timeFrame: 20 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 AA, Tebbetts S, Darbes LA, Hahn JA, Neilands TB, McKenna SA, Mulauzi N, Mkandawire J, Ssewamala FM. Development of an Economic and Relationship-Strengthening Intervention for Alcohol Drinkers Living with HIV in Malawi. AIDS Behav. 2023 Jul;27(7):2255-2270. doi: 10.1007/s10461-022-03956-3. Epub 2022 Dec 15.
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.