NCT04906616

Brief Summary

A couples-based alcohol-reduction and economic and relationship-strengthening intervention for HIV-affected couples in Malawi.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
156

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 25, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 28, 2021

Completed
3 days until next milestone

Study Start

First participant enrolled

May 31, 2021

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 13, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 13, 2023

Completed
7 months until next milestone

Results Posted

Study results publicly available

February 20, 2024

Completed
Last Updated

February 20, 2024

Status Verified

January 1, 2024

Enrollment Period

2.1 years

First QC Date

May 25, 2021

Results QC Date

December 13, 2023

Last Update Submit

January 24, 2024

Conditions

HIV/AIDSAlcohol Abuse

Outcome Measures

Primary Outcomes (2)

  • 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

Secondary Outcomes (6)

  • Percentage of Couples Who Are "Satisfied" or "Very Satisfied" With the Intervention at 10 Months

    10 months

  • Percentage of Couples Who Are Satisfied With the Intervention at 15 Months

    15 months

  • 10 Month Follow up Survey Completion

    10 months

  • 15 Month Follow up Survey Completion

    15 months

  • 75% Intervention Completion

    10 months

  • +1 more secondary outcomes

Other Outcomes (4)

  • Exploratory: Alcohol Use

    10 months, 15 months

  • Exploratory: Alcohol Use

    10 months, 15 months

  • Exploratory: Viral Suppression

    10 months, 15 months

  • +1 more other outcomes

Study Arms (2)

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.

Behavioral: Mlambe

Interventions

MlambeBEHAVIORAL

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.

Mlambe Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • in a married or cohabitating union
  • have at least one partner with a positive AUDIT-C screen in prior 3 months who is also currently on ART for at least 6 months who has disclosed their HIV status to their partner

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Invest in Knowledge Initiative (IKI)

Zomba, Malawi

Location

Related Publications (7)

  • 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.

    PMID: 28398134BACKGROUND

  • 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.

    PMID: 30218319BACKGROUND

  • 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.

    PMID: 31456201BACKGROUND

  • 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.

    PMID: 30730356BACKGROUND

  • 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.

    PMID: 19520472BACKGROUND

  • 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.

    PMID: 29846836BACKGROUND

  • 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.

    PMID: 40104040DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency SyndromeAlcoholism

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesAlcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Results Point of Contact

Title
Dr. Amy Conroy
Organization
University of California, San Francisco
Amy.Conroy@ucsf.edu
415-476-6021

Study Officials

  • Amy Conroy, PhD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Couples will be randomized 1:1 to intervention or control arm
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 25, 2021

First Posted

May 28, 2021

Study Start

May 31, 2021

Primary Completion

July 13, 2023

Study Completion

July 13, 2023

Last Updated

February 20, 2024

Results First Posted

February 20, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

MA(1)