Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06367348
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-24
First Post:
2024-04-10
Brief Title:
An Economic and Relationship-strengthening Intervention to Reduce Alcohol Use in Malawi
Sponsor:
University of California San Francisco
Organization:
University of California San Francisco
Study Overview
Official Title:
Mlambe A Randomized Controlled Trial of an Economic and Relationship-Strengthening Intervention to Reduce Alcohol Use in Malawi
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 eg better communication less IPV as compared to EUC participants
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 eg better communication less IPV as compared to EUC participants
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01AA031445 | NIH | None | httpsreporternihgovquickSearchR01AA031445 |