Clinical trial NCT06415357: Zambia Healthy Choices Project for Emerging Adults Living With HIV
Official title: Adapting mHealth Interventions to Improve Self-management of HIV and Substance Use Among Emerging Adults in Zambia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pre-Exposure Prophylaxis
Keywords: Pre-Exposure Prophylaxis (PrEP)
HIV Prevention
mHealth
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: University of Zambia
First posted: 2024-05-16
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Intervention Acceptability: System Usability Score (SUS)
timeFrame: Month 3
measure: Intervention Acceptability: System Usability Score (SUS)
timeFrame: Month 6
measure: Intervention Acceptability: Client Satisfaction Questionnaire (CSQ-8)
timeFrame: Month 3
measure: Intervention Acceptability: Client Satisfaction Questionnaire (CSQ-8)
timeFrame: Month 6
measure: Intervention Acceptability: Exit Interview
timeFrame: Month 3
measure: Intervention Feasibility: Participant Retention
timeFrame: Baseline to Month 6
measure: Intervention Feasibility: Number of Responses to MTM
timeFrame: Baseline to Month 6
measure: Intervention Feasibility: Number of mHC Sessions Completed
timeFrame: Baseline to Month 6
measure: ART Adherence: Visual Analog Scale
timeFrame: Baseline, Month 3, and Month 6
measure: ART Adherence: Self-Reported Adherence
timeFrame: Baseline, Month 3, and Month 6
measure: ART Adherence: Dried Blood Spot (DBS) Testing
timeFrame: Baseline, Month 3, and Month 6
measure: Alcohol Use: The Timeline Followback (TLFB) Interview
timeFrame: Baseline, Month 3, and Month 6
Secondary outcomes:
measure: Information: HIV Knowledge
timeFrame: Baseline, Month 3, and Month 6
measure: Information: ART Knowledge
timeFrame: Baseline, Month 3, and Month 6
measure: Motivation: Rollnick's Readiness Ruler
timeFrame: Baseline, Month 3, and Month 6
measure: Motivation: Decisional Balance for Problem Behavior
timeFrame: Baseline, Month 3, and Month 6
measure: Behavioral Skills: Self-Efficacy
timeFrame: Baseline, Month 3, and Month 6
measure: STI Diagnosis: Number of participants who are diagnosed with syphilis, gonorrhea, or chlamydia
timeFrame: Baseline and Month 6
measure: Sexual Risk
timeFrame: Baseline, Month 3, and Month 6
measure: Drug Use: Alcohol, Smoking and Substance Involvement Screening Test (ASSIST)
timeFrame: Baseline, Month 3, and Month 6
measure: Drug Use: Alcohol Use Disorder Identification Text (AUDIT-C)
timeFrame: Baseline, Month 3, and Month 6
measure: Mental health: Brief Symptom Inventory (BSI-18)
timeFrame: Baseline, Month 3, and Month 6
measure: Social support: Social Provision Scale
timeFrame: Baseline, Month 3, and Month 6
measure: HIV stigma: Shortened Version of Berger's Stigma Scale
timeFrame: Baseline, Month 3, and Month 6
Other outcomes:
Locations:
city: Lusaka
country: Zambia
facility: University of Zambia
Study officials:
affiliation: University of Massachusetts, Worcester
name: Bo Wang, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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