An interventional study of Mlambe in HIV/AIDS and Alcohol Abuse, sponsored by University of California, San Francisco. Completed at 1 site in Malawi. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-02-20.
Sponsored by University of California, San Francisco · Not applicable, Interventional, and Supportive care
A couples-based alcohol-reduction and economic and relationship-strengthening intervention for HIV-affected couples in Malawi.
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.
1,606 studies on the registry are indexed under Alcoholism; 329 are open to participants now.
This study's enrollment of 156 is above the median of 87 across 1,371 interventional studies indexed under Alcoholism.
Browse Alcoholism studies →University of California, San Francisco is the lead sponsor of 2,132 studies on the registry; 375 are open to participants now.
Of its 262 completed or terminated interventional studies of FDA-regulated products, 196 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Standard of care, e.g. regular HIV care plus brief advice on alcohol use
A couples-based intervention to reduce problematic drinking and improve economic and HIV outcomes.
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.
Enrollment Rate
Percentage of eligible couples enrolled in the study.
Time frame: Baseline (Time 0)
Retention Rate
Percentage of enrolled and randomized participants retained at the end of the study
Time frame: 15 months
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.
Time frame: 10 months
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.
Time frame: 15 months
10 Month Follow up Survey Completion
Percentage of couples who complete follow up surveys at 10 months
Time frame: 10 months
15 Month Follow up Survey Completion
Percentage of couples who complete follow up surveys at 15 months
Time frame: 15 months
75% Intervention Completion
Percentage of couples who attend 75% of intervention sessions
Time frame: 10 months
100% Intervention Completion
Percentage of couples who attend 100% of intervention sessions
Time frame: 10 months
Exploratory: Alcohol Use
Number of drinking days in the past 21 days, assessed via the Timeline Follow-Back Method
Time frame: 10 months, 15 months
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)
Time frame: 10 months, 15 months
Exploratory: Viral Suppression
Proportion of HIV-infected participants who are virally suppressed by local lab normal ranges, as measured by dried blood spots (DBS)
Time frame: 10 months, 15 months
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
Time frame: 10 months, 15 months
| Milestone | Control Comparison | Mlambe Intervention |
|---|---|---|
| Started | 78 | 78 |
| Completed | 75 | 76 |
| Not completed | 3 | 2 |
| Withdrew: Divorce | 3 | 2 |
Percentage of eligible couples enrolled in the study.
| couples | Enrollment Rate |
|---|---|
| Enrollment Rate | 84 |
Percentage of enrolled and randomized participants retained at the end of the study
| Participants | Control Comparison | Mlambe Intervention |
|---|---|---|
| Retention Rate | 75 | 76 |
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.
| couples | Control Comparison | Mlambe Intervention |
|---|---|---|
| Percentage of Couples Who Are "Satisfied" or "Very Satisfied" With the Intervention at 10 Months | 39 | 39 |
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.
| couples | Control Comparison | Mlambe Intervention |
|---|---|---|
| Percentage of Couples Who Are Satisfied With the Intervention at 15 Months | 39 | 39 |
Percentage of couples who complete follow up surveys at 10 months
| couples | Control Comparison | Mlambe Intervention |
|---|---|---|
| 10 Month Follow up Survey Completion | 36 | 38 |
Percentage of couples who complete follow up surveys at 15 months
| couples | Control Comparison | Mlambe Intervention |
|---|---|---|
| 15 Month Follow up Survey Completion | 37 | 37 |
Percentage of couples who attend 75% of intervention sessions
| couples | Control Comparison | Mlambe Intervention |
|---|---|---|
| 75% Intervention Completion | 39 | 39 |
Percentage of couples who attend 100% of intervention sessions
| couples | Control Comparison | Mlambe Intervention |
|---|---|---|
| 100% Intervention Completion | 39 | 39 |
Number of drinking days in the past 21 days, assessed via the Timeline Follow-Back Method
Results for this outcome have not been posted.
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)
Results for this outcome have not been posted.
Proportion of HIV-infected participants who are virally suppressed by local lab normal ranges, as measured by dried blood spots (DBS)
Results for this outcome have not been posted.
Proportion of pills taken by HIV-infected participants in the past 30 days, using the bean count method (self-report) adapted from VAS
Results for this outcome have not been posted.
Collected over 15 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Control Comparison | 0/78 (0%) | 0/78 (0%) | 0/78 (0%) |
| Mlambe Intervention | 1/78 (1.3%) | 0/78 (0%) | 0/78 (0%) |
| Age, Continuous(Years) | Control Comparison | Mlambe Intervention | Total |
|---|---|---|---|
| Mean | 43.7 ± 10.3 | 43.2 ± 10.1 | 43.4 ± 10.2 |
| Sex: Female, Male(Participants) | Control Comparison | Mlambe Intervention | Total |
|---|---|---|---|
| Female | 39 | 39 | 78 |
| Male | 39 | 39 | 78 |
| Race (NIH/OMB)(Participants) | Control Comparison | Mlambe Intervention | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 78 | 78 | 156 |
| White | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Control Comparison | Mlambe Intervention | Total |
|---|---|---|---|
| Malawi | 78 | 78 | 156 |
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University of California, San Francisco