An Economic and Relationship-strengthening Intervention for HIV-affected Couples Who Drink Alcohol in Malawi
Phase: NA
Conditions: HIV/AIDS, Alcohol Abuse
Sponsor: University of California, San Francisco

 
 
Official Study Title:  An Economic and Relationship-strengthening Intervention for HIV-
affected Couples Who Drink Alcohol in Malawi 
 
NCT #:  NCT04906616 
 
December 4, 2023 
 
 
Study Protocol and Statistical Analysis Plan 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
  
 
Mlambe Protocol 
 
For Aim 1, we will adapt and integrate two efficacious interventions (Suubi and 
Uthando Lwethu) into a combined intervention targeting alcohol use in HIV-
affected couples. After developing a draft of the intervention manual, we will 
conduct 5 focus group discussions with key stakeholders (e.g., HIV care providers, 
village and religious authorities, traditional marriage counselors, microfinance and 
banking representatives) and couples from the target population. Findings will be 
analyzed and incorporated into the intervention.  
  
For Aim 2, we will develop the materials to conduct a pilot RCT of the intervention 
in order to assess feasibility and acceptability. Materials to be developed include 
randomization procedures, intervention manuals, training procedures, study 
procedures, and study instruments.  
  
For Aim 3, we will recruit 80 couples with at least one partner on ART who is a 
heavy alcohol user from two HIV clinics in Malawi to participate in the pilot RCT 
(40 couples per arm). Couples will be screened for inclusion in the study and will 
complete baseline surveys directly following consent and enrollment.  Following 
the completion of baseline surveys, couples will be randomized to either the 
control or intervention arm in blocks of 20 couples each until the sample size is 
reached. A block randomization schema will be generated by the project 
statisticians using SAS.  Couples will be given sealed envelopes containing their 
randomized assignment. Couples randomized to the control arm will privately 
receive brief alcohol advice (5-10 minutes) immediately following notification of 
their randomization assignment (see the Mlambe manual for details related the 
brief alcohol advice).  The brief alcohol advice will include accurate alcohol and 
ARV risk reduction information and will serve as a basis for comparison to 
additional alcohol-related activities in the intervention arm.  Couples randomized 
to the intervention arm will be scheduled for the first of ten sessions, held 
monthly, related to financial literacy and couple communication.  Couples from 
both the control and intervention arms will complete surveys administered to 
both partners at baseline, ten months past baseline, and 15 months past baseline. 

Couples will also be asked to provide a small sample of blood at ten months past 
baseline. If blood samples are lost by the lab or rendered unusable due to 
unforeseen issues, we will ask participants to return for an additional blood draw 
following the 10-month assessment visit. We will collect tracking data on 
feasibility and acceptability of the intervention. At the end of the study, we will 
conduct qualitative exit interviews with 20 couples. All data will be used to refine 
the intervention and prepare for a full-scale efficacy trial (future grant/study).  
 
 
Mlambe StaWsWcal Plan 
 
The primary staWsWcal analyses will include descripWve staWsWcs of the feasibility 
and acceptability indicators, comparing each staWsWc (e.g., % retained) to the 
corresponding threshold. Above-threshold ﬁndings will suggest a reasonable level 
of feasibility and acceptability for the corresponding aspects of study procedures. 
Below-threshold ﬁndings would suggest that remedial modiﬁcaWons to study 
procedures and/or design would be required prior to moving forward with a full-
scale trial; qualitaWve analyses of the exit interviews described below will be 
instrucWve under this circumstance.  
 
For the outcomes assessed in the future trial, we will compute descripWve 
staWsWcs to capture measures of central tendency for conWnuous variables and 
proporWons for binary variables. We will also conduct a trial run of our planned 
analysis procedures for the future RCT to ensure that the requisite data are 
collected and to reﬁne staWsWcal methods for issues such as missing data and non-
normally distributed variables.