Health TrialsbyHealthPanel

Thailand HIV and Stigma Reduction Study

ConditionPre-Exposure Prophylaxis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18-29
SponsorUniversity of Massachusetts, Worcester

About this trial

This project will develop a multi-component, technology-delivered intervention designed to reduce HIV and intersectional stigma and improve the use of HIV pre-exposure prophylaxis (PrEP) among HIV-negative Thai vulnerable emerging adults (18-29 years).

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Ages between 18 and 29 years

Male sex at birth

Self-identifies as women, transgender women or culturally identifies with the female spectrum

Laboratory-confirmed HIV-negative status

Disqualifiers

Have a serious cognitive or psychiatric problem compromising ability to provide informed consent

Have active suicidal ideation or major mental illness at the time of interview (these patients will be referred for treatment)

Laboratory or clinical findings that would preclude PrEP initiation (e.g., decreased creatinine clearance)

Currently enrolled in another HIV intervention study.

Trial design

Design model

Factorial

Treatments tested in this trial

  • Mobile Healthy Choices (mHC)

    Behavioral

    mHC is a four-session, 20-minute, motivational interviewing-based intervention, which will be delivered on the CIAS platform. It will be tailored to participants' responses given during the interaction in the intervention. In the first two sessions, the (virtual) counselor will motivate participants to overcome stigma and utilize HIV prevention services by using tailored motivational interviewing strategies, develop an individualized change goal based on their readiness, and provide cognitive behavioral strategies. In the last two sessions, the counselor will review the change plan, monitor progress, and provide support for sustained behavioral change. The sessions will occur within three months after baseline.

  • Finding Respect and Ending Stigma around HIV (FRESH)

    Behavioral

    FRESH content includes six 10-15 minute sessions with interactive, culturally sensitive multimedia modules, which will be delivered on the CIAS platform. The content will aim to improve self-efficacy, reduce intersectional stigmas and promote HIV preventative behaviors. The sessions will occur within three months after baseline.

  • Standard PrEP Counseling

    Behavioral

    All participants will receive one-on-one, face to face counseling from focusing on sexual and behavioral risk assessment for HIV/STIs, risk reduction, and HIV prevention. For those not on PrEP, the sessions will focus on risk perception, awareness of PrEP, and facilitators and barriers to PrEP access. For those on PrEP, the sessions will focus on adherence. The counseling will be provided at baseline, 3 months, and 6 months.

Treatment groups

154 Participants
are divided into 4 treatment groups
Group A: Standard PrEP counseling, mHC, and FRESH contentExperimental treatment 3 interventions
Group B: Standard PrEP counseling and mHCExperimental treatment 2 interventions
Group C: Standard PrEP counseling and FRESH contentExperimental treatment 2 interventions
Group D: Standard PrEP counselingExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Intervention Acceptability: System Usability Score (SUS)

The SUS is a 10-item, 5-point Likert scale for evaluating subjective usability. Each item is scored from 1 to 5, with the calculation involving either subtracting 1 from the user response or the user response from 5 depending on the item. The scores are then summed and multiplied by 2.5 to obtain a total score ranging from 0 to 100. A score above 80 indicates that the intervention is acceptable.

Time frame
Month 3, Month 6
2

Intervention Acceptability: Exit Interview

Participants will be asked about their experiences using mHC and FRESH content and potential improvements.

Time frame
Month 3
3

Intervention Feasibility: Participant retention

Participant retention rate of over 85% at 6-month follow-up will be the minimum criterion for feasibility.

Time frame
Baseline through Month 6
4

Intervention Feasibility: Number of FRESH sessions viewed

Intervention feasibility will be evaluated by the total number of FRESH sessions viewed.

Time frame
Baseline through Month 6

Secondary outcomes

1

Empowerment

Empowerment will be assessed using the Healthcare Empowerment Inventory. It's an 8-item, 5-point Likert scale, with total scores ranging from 8 to 40. Higher scores indicate a greater sense of empowerment in her health care.

Time frame
Baseline, Month 3, and Month 6
2

Information: HIV Knowledge

HIV transmission risk awareness will be assessed through an 18-item HIV Knowledge Questionnaire. The total scores can range from 0 to 18, with higher scores indicating a higher level of HIV knowledge.

Time frame
Baseline, Month 3, and Month 6
3

Information: PrEP Knowledge

PrEP knowledge will be assessed through a 13-item PrEP Knowledge Scale. The total score can range from 0 to 13, with higher scores indicating a higher level of PrEP knowledge.

Time frame
Baseline, Month 3, and Month 6
4

Motivation: Rollnick's Readiness Ruler

Motivation 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 in HIV prevention and risk behaviors.

Time frame
Baseline, Month 3, and Month 6

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Massachusetts, Worcester

Lead sponsor

National Institute of Mental Health (NIMH)

Collaborator

Institute of HIV Research and Innovation Foundation, Thailand

Collaborator

Source ClinicalTrials.gov
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