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NCT06367348 | NOT YET RECRUITING | HIV/AIDS


An Economic and Relationship-strengthening Intervention to Reduce Alcohol Use in Malawi
Sponsor:

University of California, San Francisco

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.

Condition or disease

HIV/AIDS

Alcohol Abuse

Intervention/treatment

Mlambe

Phase

NA

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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 500 participants
Masking : NONE
Primary Purpose : SUPPORTIVE_CARE
Official Title : Mlambe: A Randomized Controlled Trial of an Economic and Relationship-Strengthening Intervention to Reduce Alcohol Use in Malawi
Actual Study Start Date : 2025-01
Estimated Primary Completion Date : 2028-05
Estimated Study Completion Date : 2028-05

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
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)

An Economic and Relationship-strengthening Intervention to Reduce Alcohol Use in Malawi

Location Details

NCT06367348


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Locations


Not yet recruiting

Malawi,

Invest in Knowledge Initiative (IKI)

Zomba, Malawi,

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