Adapting mHealth Interventions to Improve Self-management of HIV and Substance Use Among Emerging Adults in Zambia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 164
- 试验地点
- 1
- 主要终点
- Intervention Acceptability: Client Satisfaction Questionnaire (CSQ-8)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 24 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •Have a serious cognitive or psychiatric problem that would compromise ability to provide informed consent
- •currently enrolled in another HIV intervention study
研究组 & 干预措施
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.
干预措施: Motivational Text Messaging (MTM) (Behavioral)
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.
干预措施: Standard ART Counseling (Behavioral)
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.
干预措施: Mobile Healthy Choices (mHC) (Behavioral)
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.
干预措施: Motivational Text Messaging (MTM) (Behavioral)
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.
干预措施: Mobile Healthy Choices (mHC) (Behavioral)
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.
干预措施: Standard ART Counseling (Behavioral)
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.
干预措施: Standard ART Counseling (Behavioral)
Standard ART counseling
Participants in this arm will receive standard ART counseling.
干预措施: Standard ART Counseling (Behavioral)
结局指标
主要结局
Intervention Acceptability: Client Satisfaction Questionnaire (CSQ-8)
时间窗: 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.
Intervention Acceptability: Exit Interview
时间窗: 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.
Intervention Acceptability: System Usability Score (SUS)
时间窗: 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.
Intervention Feasibility: Number of Responses to MTM
时间窗: Baseline to Month 6
Intervention feasibility will be evaluated by the total number of responses to MTM.
ART Adherence: Visual Analog Scale
时间窗: 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.
ART Adherence: Self-Reported Adherence
时间窗: 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.
ART Adherence: Dried Blood Spot (DBS) Testing
时间窗: 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.
Alcohol Use: The Timeline Followback (TLFB) Interview
时间窗: 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.
Intervention Feasibility: Participant Retention
时间窗: 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.
Intervention Feasibility: Number of mHC Sessions Completed
时间窗: Baseline to Month 6
Intervention feasibility will be evaluated by the number of completed intervention sessions.
Intervention Acceptability: System Usability Score (SUS)
时间窗: 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.
Intervention Acceptability: Client Satisfaction Questionnaire (CSQ-8)
时间窗: 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.
次要结局
- Sexual Risk(Baseline, Month 3, and Month 6)
- Information: HIV Knowledge(Baseline, Month 3, and Month 6)
- Drug Use: Alcohol Use Disorder Identification Text (AUDIT-C)(Baseline, Month 3, and Month 6)
- Behavioral Skills: Self-Efficacy(Baseline, Month 3, and Month 6)
- Mental health: Brief Symptom Inventory (BSI-18)(Baseline, Month 3, and Month 6)
- Information: ART Knowledge(Baseline, Month 3, and Month 6)
- Motivation: Decisional Balance for Problem Behavior(Baseline, Month 3, and Month 6)
- STI Diagnosis: Number of participants who are diagnosed with syphilis, gonorrhea, or chlamydia(Baseline and Month 6)
- Drug Use: Alcohol, Smoking and Substance Involvement Screening Test (ASSIST)(Baseline, Month 3, and Month 6)
- Social support: Social Provision Scale(Baseline, Month 3, and Month 6)
- HIV stigma: Shortened Version of Berger's Stigma Scale(Baseline, Month 3, and Month 6)
- Motivation: Rollnick's Readiness Ruler(Baseline, Month 3, and Month 6)
研究者
Bo Wang
Professor
University of Massachusetts, Worcester