Zambia Healthy Choices Project for Emerging Adults Living With HIV

May 14, 2024 updated by: Bo Wang, University of Massachusetts, Worcester

Adapting mHealth Interventions to Improve Self-management of HIV and Substance Use Among Emerging Adults in Zambia

This project will develop and implement a multi-component intervention using mobile health technology to improve HIV self-management and reduce substance use. Specifically, the investigators will adapt Healthy Choices (HC) to develop mobile HC (mHC) and develop Motivational text messaging (MTM) for Zambian emerging adults living with HIV.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Zambia
      • Lusaka, Zambia
        • Recruiting
        • University of Zambia
        • Contact:
        • Principal Investigator:
          • Joseph Zulu, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Zambian emerging adults living with HIV

Inclusion Criteria:

  • Aged between 18 and 24 years
  • Report visual analogue scale showing <80% medication adherence in the last month AND problematic/risky alcohol use in the last month
  • Speak English, Nyanja, or Bemba

Exclusion Criteria:

  • Have a serious cognitive or psychiatric problem that would compromise ability to provide informed consent
  • currently enrolled in another HIV intervention study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Standard ART counseling, mHC, and MTM
Participants in this arm will receive standard ART counseling, followed by two mHealth interventions (mHC and MTM) to improve PrEP uptake and adherence.
Behavioral: Mobile Healthy Choices (mHC)
mHC is a four-session computer-delivered intervention based on the Information-Motivation-Behavioral (IMB) model and socioecological model (SEM). Using motivational interviewing, it tailors content to participants' responses. Sessions 1 and 2 focus on HIV self-management and alcohol reduction, gauging importance, confidence, and goals. Strengths, barriers, resources, and strategies are explored. Sessions 3 and 4 review goals, reinforce importance, confidence, and motivation, and strategize behavior maintenance. Over two months, participants engage in goal-oriented sessions, promoting sustained behavior change.
Behavioral: Motivational Text Messaging (MTM)
Text messages with motivational statements will be sent to participants based on their readiness to change, as assessed during mHC session 1. The statements promoting HIV self-management and alcohol use reduction will be derived from an MTM library written by Zambian young people living with HIV. MTM will be delivered to participants daily for two months and weekly for an additional four months at a time that a participant prefers.
Behavioral: Standard ART Counseling
All participants will receive one-on-one, face-to-face in clinic. Standard ART counseling includes the management and treatment of HIV, reproductive health, substance abuse, and mental health. They will also be counseled about treatment adherence and side-effect management.
Experimental: Standard ART counseling and mHC
Participants in this arm will receive standard ART counseling, followed by one mHealth intervention (mHC) to improve PrEP uptake and adherence.
Behavioral: Mobile Healthy Choices (mHC)
mHC is a four-session computer-delivered intervention based on the Information-Motivation-Behavioral (IMB) model and socioecological model (SEM). Using motivational interviewing, it tailors content to participants' responses. Sessions 1 and 2 focus on HIV self-management and alcohol reduction, gauging importance, confidence, and goals. Strengths, barriers, resources, and strategies are explored. Sessions 3 and 4 review goals, reinforce importance, confidence, and motivation, and strategize behavior maintenance. Over two months, participants engage in goal-oriented sessions, promoting sustained behavior change.
Behavioral: Standard ART Counseling
All participants will receive one-on-one, face-to-face in clinic. Standard ART counseling includes the management and treatment of HIV, reproductive health, substance abuse, and mental health. They will also be counseled about treatment adherence and side-effect management.
Experimental: Standard ART counseling and MTM
Participants in this arm will receive standard ART counseling, followed by one mHealth intervention (MTM) to improve PrEP uptake and adherence.
Behavioral: Motivational Text Messaging (MTM)
Text messages with motivational statements will be sent to participants based on their readiness to change, as assessed during mHC session 1. The statements promoting HIV self-management and alcohol use reduction will be derived from an MTM library written by Zambian young people living with HIV. MTM will be delivered to participants daily for two months and weekly for an additional four months at a time that a participant prefers.
Behavioral: Standard ART Counseling
All participants will receive one-on-one, face-to-face in clinic. Standard ART counseling includes the management and treatment of HIV, reproductive health, substance abuse, and mental health. They will also be counseled about treatment adherence and side-effect management.
Active Comparator: Standard ART counseling
Participants in this arm will receive standard ART counseling.
Behavioral: Standard ART Counseling
All participants will receive one-on-one, face-to-face in clinic. Standard ART counseling includes the management and treatment of HIV, reproductive health, substance abuse, and mental health. They will also be counseled about treatment adherence and side-effect management.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intervention Acceptability: System Usability Score (SUS)
Time Frame: Month 3
SUS is a 10-item, 5-point Likert scale for subjective assessment of usability. Each item ranges from 1 to 5. Depending on the item, the score is calculated by subtracting either one from the user response or the user response from 5. Then, the score for each item will be summed and multiplied by 2.5 for the total score. The overall SUS scores range from 0 to 100. A score of > 50 indicates that the technology-based interventions are acceptable.
Month 3
Intervention Acceptability: System Usability Score (SUS)
Time Frame: Month 6
SUS is a 10-item, 5-point Likert scale for subjective assessment of usability. Each item ranges from 1 to 5. Depending on the item, the score is calculated by subtracting either one from the user response or the user response from 5. Then, the score for each item will be summed and multiplied by 2.5 for the total score. The overall SUS scores range from 0 to 100. A score of > 50 indicates that the technology-based interventions are acceptable.
Month 6
Intervention Acceptability: Client Satisfaction Questionnaire (CSQ-8)
Time Frame: Month 3
CSQ-8 is an 8-item, 4-point Likert scale measuring the construct of global intervention satisfaction. The total possible composite score ranges from 8 to 32, with higher scores indicating greater acceptability.
Month 3
Intervention Acceptability: Client Satisfaction Questionnaire (CSQ-8)
Time Frame: Month 6
CSQ-8 is an 8-item, 4-point Likert scale measuring the construct of global intervention satisfaction. The total possible composite score ranges from 8 to 32, with higher scores indicating greater acceptability.
Month 6
Intervention Acceptability: Exit Interview
Time Frame: Month 3
Participants will be invited to share their experiences with mHC and MTM, including feedback on acceptability, ease of use, suggestions for improvement, and impact on ART adherence and alcohol use reduction.
Month 3
Intervention Feasibility: Number of Responses to MTM
Time Frame: Baseline to Month 6
Intervention feasibility will be evaluated by the total number of responses to MTM.
Baseline to Month 6
Intervention Feasibility: Number of mHC Sessions Completed
Time Frame: Baseline to Month 6
Intervention feasibility will be evaluated by the number of completed intervention sessions.
Baseline to Month 6
ART Adherence: Visual Analog Scale
Time Frame: Baseline, Month 3, and Month 6
ART adherence will be assessed through the Young Adult Adherence Interview via computer-assisted self-interview (CASI) survey, which contains a visual analog scale (VAS) ranging from 0 to 100. Higher percentages on the VAS indicate greater adherence to ART.
Baseline, Month 3, and Month 6
ART Adherence: Self-Reported Adherence
Time Frame: Baseline, Month 3, and Month 6
ART adherence will be evaluated through self-reported adherence over the past four weeks via a CASI survey. Participants will rate their adherence on a scale ranging from 0 to 100%, with higher percentages indicating better adherence to ART.
Baseline, Month 3, and Month 6
ART Adherence: Dried Blood Spot (DBS) Testing
Time Frame: Baseline, Month 3, and Month 6
ART adherence will be evaluated by examining the HIV viral load in DBS. Maintaining a viral load of less than 200 copies/ml will indicate adherence to ART.
Baseline, Month 3, and Month 6
Alcohol Use: The Timeline Followback (TLFB) Interview
Time Frame: Baseline, Month 3, and Month 6
Alcohol use will be assessed using the TLFB interview. Using a calendar, participants will be asked to provide estimates of their daily drinking over the last 30 days, as well as the max number of drinks in a one-week period, the number of heavy drinking days, the number of standard drinks in 30 days, and binge drinking.
Baseline, Month 3, and Month 6
Intervention Feasibility: Participant Retention
Time Frame: Baseline to Month 6
Intervention feasibility will be assessed based on participant retention at Month 6. The retention rate can range from 70 to 90%, with a retention rate of over 85% deemed the minimum criterion for feasibility.
Baseline to Month 6

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Information: HIV Knowledge
Time Frame: Baseline, Month 3, and Month 6
HIV transmission risk awareness will be evaluated through an 18-item HIV Knowledge Questionnaire. Total possible composite scores range from 0 to 18, with higher scores indicating a higher level of HIV knowledge.
Baseline, Month 3, and Month 6
Information: ART Knowledge
Time Frame: Baseline, Month 3, and Month 6
ART knowledge will be evaluated through a 21-item HIV Treatment Knowledge Questionnaire. Total possible composite scores range from 0 to 21, with higher scores indicating a higher level of ART knowledge.
Baseline, Month 3, and Month 6
Motivation: Rollnick's Readiness Ruler
Time Frame: Baseline, Month 3, and Month 6
Intentions to improve HIV self-management and alcohol consumption behaviors will be evaluated using the 5-item Rollnick's Readiness Ruler. Each item ranges from 0 to 10, with higher scores indicating a greater readiness for change.
Baseline, Month 3, and Month 6
Motivation: Decisional Balance for Problem Behavior
Time Frame: Baseline, Month 3, and Month 6
Attitudes toward risk behaviors will be assessed using the 32-item Decisional Balance for Problem Behavior scale. This 5-point Likert scale evaluates the perceived pros and cons of engaging in risk behaviors
Baseline, Month 3, and Month 6
Sexual Risk
Time Frame: Baseline, Month 3, and Month 6
Sexual risk will be assessed using TLFB interview via CASI, capturing sexual behavior over the past 30 days, such as condom usage and the number of sexual partners.
Baseline, Month 3, and Month 6
Drug Use: Alcohol, Smoking and Substance Involvement Screening Test (ASSIST)
Time Frame: Baseline, Month 3, and Month 6
Drug use will be assessed with ASSIST, which is a questionnaire to identify substance use health risks and disorders, with each item scored from 0 to 12. The total score ranges up to 24, with higher scores indicating greater risk based on current substance use patterns.
Baseline, Month 3, and Month 6
Drug Use: Alcohol Use Disorder Identification Text (AUDIT-C)
Time Frame: Baseline, Month 3, and Month 6
Alcohol use will be assessed by using AUDIT-C to identify individuals with hazardous drinking habits or alcohol use disorders. Each item scores from 0 to 4, with 0 indicating no alcohol consumption. The total score maxes out at 12, with higher scores suggesting greater risks of harm.
Baseline, Month 3, and Month 6
Mental health: Brief Symptom Inventory (BSI-18)
Time Frame: Baseline, Month 3, and Month 6
Mental health will be evaluated with BSI-18. This 18-item questionnaire utilizes a 5-point Likert scale to gauge psychological distress. Scores range up to 72, with higher scores indicating a higher level of psychological distress.
Baseline, Month 3, and Month 6
Social support: Social Provision Scale
Time Frame: Baseline, Month 3, and Month 6
Social support will be evaluated using the Social Provision Scale. This 5-point Likert scale, 13-item survey assesses the availability of social support, such as emotional, information, and instrumental support, as well as companionship and social isolation. Scores range up to 65, with higher scores indicating more extensive availability of social support.
Baseline, Month 3, and Month 6
Behavioral Skills: Self-Efficacy
Time Frame: Baseline, Month 3, and Month 6
Behavioral skills in HIV self-management will be assessed using a 5-item adapted version of the Self-Efficacy for Health Promotion and Risk Reduction Questionnaire. This 5-point Likert scale measures confidence levels (score range: 5-25), with higher scores indicating greater confidence in HIV self-management tasks.
Baseline, Month 3, and Month 6
STI Diagnosis: Number of participants who are diagnosed with syphilis, gonorrhea, or chlamydia
Time Frame: Baseline and Month 6
Syphilis testing will employ a treponemal test with rapid plasma reagin (RPR), while gonorrhea and chlamydia testing will utilize pooled urine, oropharyngeal, and rectal swabs.
Baseline and Month 6
HIV stigma: Shortened Version of Berger's Stigma Scale
Time Frame: Baseline, Month 3, and Month 6
HIV-related stigma will be evaluated using the 10-item Berger's Stigma Scale. This scale, based on a 4-point Likert scale, assesses the stigma perceived by people living with HIV. The score can range from 10 to 40, with a higher score indicating greater perceived stigma associated with HIV.
Baseline, Month 3, and Month 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Massachusetts, Worcester

Collaborators

National Institute on Drug Abuse (NIDA)
University of Zambia

Investigators

  • Principal Investigator: Bo Wang, PhD, University of Massachusetts, Worcester

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 20, 2024

Primary Completion (Estimated)

January 31, 2026

Study Completion (Estimated)

July 31, 2026

Study Registration Dates

First Submitted

May 10, 2024

First Submitted That Met QC Criteria

May 10, 2024

First Posted (Actual)

May 16, 2024

Study Record Updates

Last Update Posted (Actual)

May 16, 2024

Last Update Submitted That Met QC Criteria

May 14, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • STUDY00001496
  • 1R34DA059935 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All IPD collected during the trial, after deidentification.

IPD Sharing Time Frame

Immediately following publication. No end date.

IPD Sharing Access Criteria

Anyone who wises to access the data.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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