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| ID | Type | Description | Link |
|---|---|---|---|
| R34AA027983-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
| Invest in Knowledge Initiative (IKI) - Zomba, Malawi | OTHER |
| University of Michigan | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Comparison | No Intervention | Standard of care, e.g. regular HIV care plus brief advice on alcohol use | |
| Mlambe Intervention | Experimental | A couples-based intervention to reduce problematic drinking and improve economic and HIV outcomes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mlambe | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Enrollment Rate | Percentage of eligible couples enrolled in the study. | Baseline (Time 0) |
| Retention Rate | Percentage of enrolled and randomized participants retained at the end of the study | 15 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Exploratory: Alcohol Use | Number of drinking days in the past 21 days, assessed via the Timeline Follow-Back Method | 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) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Amy Conroy, PhD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Invest in Knowledge Initiative (IKI) | Zomba | Malawi |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28398134 | Background | 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. | |
| 30218319 | Background | 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. |
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The values in the data table represent individual participants and not couples.
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| ID | Title | Description |
|---|---|---|
| FG000 | Control Comparison | Standard of care, e.g. regular HIV care plus brief advice on alcohol use |
| FG001 | Mlambe Intervention | A couples-based intervention to reduce problematic drinking and improve economic and HIV outcomes. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Control Comparison | Standard of care, e.g. regular HIV care plus brief advice on alcohol use |
| BG001 | Mlambe Intervention | A couples-based intervention to reduce problematic drinking and improve economic and HIV outcomes. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Enrollment Rate | Percentage of eligible couples enrolled in the study. | 89 couples were screened as eligible for inclusion in the study. 84 couples completed baseline assessments. 78 couples (156 participants) were randomized into the study: 39 couples into the control arm and 39 couples into the intervention arm. | Posted | Count of Units | couples | Baseline (Time 0) | couples | couples |
|
|
15 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control Comparison | Standard of care, e.g. regular HIV care plus brief advice on alcohol use |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Amy Conroy | University of California, San Francisco | 415-476-6021 | Amy.Conroy@ucsf.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 4, 2023 | Dec 6, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 10, 2021 | Dec 6, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| D000437 | Alcoholism |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| Washington University School of Medicine |
| OTHER |
Couples will be randomized 1:1 to intervention or control arm
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| 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. | 15 months |
| 10 Month Follow up Survey Completion | Percentage of couples who complete follow up surveys at 10 months | 10 months |
| 15 Month Follow up Survey Completion | Percentage of couples who complete follow up surveys at 15 months | 15 months |
| 75% Intervention Completion | Percentage of couples who attend 75% of intervention sessions | 10 months |
| 100% Intervention Completion | Percentage of couples who attend 100% of intervention sessions | 10 months |
| 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) | 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 | 10 months, 15 months |
| 31456201 | Background | 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. |
| 30730356 | Background | 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. |
| 19520472 | Background | 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. |
| 29846836 | Background | 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. |
| 40104040 | Derived | Gopalakrishnan L, Mulauzi N, Mkandawire J, Ssewamala FM, Tebbetts S, Neilands TB, Conroy AA. Effects of economic empowerment and relationship strengthening intervention on financial behaviors among couples living with HIV: The Mlambe pilot trial in Malawi. SSM Popul Health. 2025 Feb 25;29:101768. doi: 10.1016/j.ssmph.2025.101768. eCollection 2025 Mar. |
| 39405663 | Derived | Conroy AA, Ruark A, Mulauzi N, Mkandawire J, Darbes LA, Hahn JA, Neilands TB, Tebbetts S, Ssewamala FM. Mlambe economic and relationship-strengthening intervention for alcohol use decreases violence and improves relationship quality in couples living with HIV in Malawi. Soc Sci Med. 2024 Dec;362:117407. doi: 10.1016/j.socscimed.2024.117407. Epub 2024 Oct 9. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| couples |
|
|
| Primary | Retention Rate | Percentage of enrolled and randomized participants retained at the end of the study | Posted | Count of Participants | Participants | 15 months |
|
|
|
| Secondary | 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. | This count here is for couples, not individuals. | Posted | Count of Units | couples | 10 months | couples | couples |
|
|
|
| Secondary | 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. | The units analyzed are for couples (not individuals) | Posted | Count of Units | couples | 15 months | couples | couples |
|
|
|
| Secondary | 10 Month Follow up Survey Completion | Percentage of couples who complete follow up surveys at 10 months | Posted | Count of Units | couples | 10 months | couples | couples |
|
|
|
| Secondary | 15 Month Follow up Survey Completion | Percentage of couples who complete follow up surveys at 15 months | Posted | Count of Units | couples | 15 months | couples | couples |
|
|
|
| Secondary | 75% Intervention Completion | Percentage of couples who attend 75% of intervention sessions | Posted | Count of Units | couples | 10 months | couples | couples |
|
|
|
| Secondary | 100% Intervention Completion | Percentage of couples who attend 100% of intervention sessions | Posted | Count of Units | couples | 10 months | couples | couples |
|
|
|
| Other Pre-specified | Exploratory: Alcohol Use | Number of drinking days in the past 21 days, assessed via the Timeline Follow-Back Method | Not Posted | 10 months, 15 months | Participants |
| Other Pre-specified | 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) | Not Posted | 10 months, 15 months | Participants |
| Other Pre-specified | Exploratory: Viral Suppression | Proportion of HIV-infected participants who are virally suppressed by local lab normal ranges, as measured by dried blood spots (DBS) | Not Posted | 10 months, 15 months | Participants |
| Other Pre-specified | 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 | Not Posted | 10 months, 15 months | Participants |
| 0 |
| 78 |
| 0 |
| 78 |
| 0 |
| 78 |
| EG001 | Mlambe Intervention | A couples-based intervention to reduce problematic drinking and improve economic and HIV outcomes. 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. | 1 | 78 | 0 | 78 | 0 | 78 |
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| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |