HIV PreventionNCT07509827
Evaluation of mHealth Intervention to Promote HIV Prevention and Overcome Stigma Among Transgender Women (EMPOW.HER)
A study testing Mobile Healthy Choices (mHC)+SPC, FRESH + SPC and mHC + FRESH + SPC in people with HIV Prevention and HIV Related Stigma, run by Institute of HIV Research and Innovation Foundation, Thailand at 3 sites in Thailand.
Trial summary
This study aims to develop and evaluate a multi-component mHealth intervention (mHC and FRESH) to reduce HIV-related and intersectional stigma and improve PrEP use among HIV-negative young transgender women (TGW) in Thailand. Read more about this study
- Who is it for?
- Ages 18 to 29 years, men only
- Conditions the study is for
- HIV Prevention, HIV Related Stigma, PrEP Adherence
- What is being tested?
- Mobile Healthy Choices (mHC)+SPC, FRESH + SPC and mHC + FRESH + SPC
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 3 sitesThailand
- Study dates
- 1 Aug 2024to 31 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 29 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Age 18-29 years
- Male sex at birth
- Self-identify as transgender woman/female spectrum
- HIV-negative (laboratory confirmed)
- Recent condomless sex
- Able to understand Thai
- Not on PrEP or poorly adherent (≤3 pills/week)
Who cannot join
- Serious cognitive or psychiatric condition affecting consent
- Active suicidal ideation or major mental illness
- Medical contraindications to PrEP
- Enrolled in another HIV intervention study
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Thailand3 sites, 3 recruiting
- Recruiting
Rainbow Sky Association of Thailand (RSAT)
Bangkok, Bangkapi, 10240
Tanachai Chaisalee, 6683 897 1691, tanachai@rsat.info
Phubet Panpet, 6663 217 1069, phubet.p@rsat.info
- Recruiting
The Service Workers In Group Foundation (SWING)
Bangkok, Building 3, Patpong, Surawong Road, 10500
Surang Janyam, 081 626 6538, surang.jan@swingthailand.org
- Recruiting
Institute of HIV Research and Innovation (IHRI)
Bangkok, Pathumwan, 10330
Rena Janamnuaysook, 6698 516 4562, rena.j@ihri.org
About this study
This study aims to develop and evaluate a multi-component mHealth intervention (mHC and FRESH) to reduce HIV-related and intersectional stigma and improve PrEP use among HIV-negative young transgender women (TGW) in Thailand.
Read the detailed description
This study uses a Multiphase Optimization Strategy (MOST) design to adapt, refine, and evaluate two mobile-based interventions: Mobile Healthy Choices (mHC) and Finding Respect and Ending Stigma around HIV (FRESH). The interventions are designed to address stigma, improve empowerment, and enhance uptake and adherence to HIV pre-exposure prophylaxis (PrEP). The study includes formative research, intervention adaptation, beta testing, and a pilot factorial randomized trial among TGW aged 18-29 in Bangkok, Thailand, with follow-up over 6 months
- Conditions
- HIV Prevention, HIV Related Stigma, PrEP Adherence
- Being tested
- Mobile Healthy Choices (mHC)+SPC, FRESH + SPC, mHC + FRESH + SPC
- Keywords
- mHealth, PrEP, HIV stigma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile Healthy Choices (mHC)+SPCBehavioural
Intervention:
- Behavioral: Mobile Healthy Choices (mHC)
- Behavioral: Standard PrEP Counseling (SPC)
FRESH + SPCBehavioural
Intervention:
- Behavioral: FRESH (Finding Respect and Ending Stigma around HIV)
- Behavioral: Standard PrEP Counseling (SPC)
mHC + FRESH + SPCBehavioural
Intervention:
- Behavioral: Mobile Healthy Choices (mHC)
- Behavioral: FRESH
- Behavioral: Standard PrEP Counseling (SPC)
| Study group | Role | What they receive |
|---|---|---|
| Standard PrEP Counseling (SPC) only | No intervention | Participants receive standard HIV prevention services including standard PrEP counseling (SPC), HIV testing, and routine care |
| mHC + SPC | Experimental | Description:
Participants receive SPC plus the mobile Healthy Choices (mHC) intervention, a 4-session (20 minutes each) motivational interviewing-based program delivered via smartphone using CIAS over 3 months to promote PrEP uptake and adherence. Receives: Behavioral: Mobile Healthy Choices (mHC)+SPC |
| FRESH + SPC | Experimental | Description:
Participants receive SPC plus FRESH, a 6-session (10-15 minutes each) multimedia intervention delivered via smartphone over 3 months to reduce HIV-related and intersectional stigma and improve empowerment. Receives: Behavioral: FRESH + SPC |
| mHC + FRESH + SPC | Experimental | Description:
Participants receive SPC plus both mHC and FRESH interventions delivered via smartphone over 3 months. Receives: Behavioral: mHC + FRESH + SPC |
What is being measured
The primary outcome is the main question the study is designed to answer.
HIV-related stigma score
HIV-related stigma (including internalized, perceived, anticipated, and enacted stigma) will be assessed using validated stigma scales. Higher scores indicate greater stigma.
Measured: Baseline, Month 3, Month 6
PrEP uptake
Proportion of participants who initiate PrEP during the study period among those not on PrEP at baseline.
Measured: Baseline through Month 6
PrEP adherence
PrEP adherence will be assessed using:
- Self-reported adherence (e.g., number of doses taken in past 7 or 30 days)
- Tenofovir diphosphate (TFV-DP) levels from dried blood spots Higher levels indicate better adherence.
Measured: Baseline, Month 3, Month 6
HIV testing uptake
Proportion of participants who complete HIV testing at each follow-up visit.
Measured: Baseline, Month 3, Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2026
- Study start1 Aug 2024
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV PreventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of HIV Research and Innovation Foundation, Thailand
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Nittaya Phanuphak, MD,PhD., Principal investigator, INSTITUTE OF HIV RESEARCH AND INNOVATION FOUNDATION
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07509827
- Sponsor's protocol ID
- IHRI034
- Status last verified
- Mar 2026
- First submitted
- 22 Mar 2026
- Last updated
- 3 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of mHealth Intervention to Promote HIV Prevention and Overcome Stigma Among Transgender Women (EMPOW.HER)
- ClinicalTrials.gov ID
- NCT07509827
- Acronym / sponsor ID
- IHRI034
- Conditions
- HIV Prevention, HIV Related Stigma, PrEP Adherence
- Keywords
- mHealth, PrEP, HIV stigma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Institute of HIV Research and Innovation Foundation, ThailandUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 3 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to develop and evaluate a multi-component mHealth intervention (mHC and FRESH) to reduce HIV-related and intersectional stigma and improve PrEP use among HIV-negative young transgender women (TGW) in Thailand.
Detailed description
This study uses a Multiphase Optimization Strategy (MOST) design to adapt, refine, and evaluate two mobile-based interventions: Mobile Healthy Choices (mHC) and Finding Respect and Ending Stigma around HIV (FRESH). The interventions are designed to address stigma, improve empowerment, and enhance uptake and adherence to HIV pre-exposure prophylaxis (PrEP). The study includes formative research, intervention adaptation, beta testing, and a pilot factorial randomized trial among TGW aged 18-29 in Bangkok, Thailand, with follow-up over 6 months
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Standard PrEP Counseling (SPC) only | No intervention | –Participants receive standard HIV prevention services including standard PrEP counseling (SPC), HIV testing, and routine care |
| mHC + SPC | Experimental | Behavioral: Mobile Healthy Choices (mHC)+SPCDescription: Participants receive SPC plus the mobile Healthy Choices (mHC) intervention, a 4-session (20 minutes each) motivational interviewing-based program delivered via smartphone using CIAS over 3 months to promote PrEP uptake and adherence. |
| FRESH + SPC | Experimental | Behavioral: FRESH + SPCDescription: Participants receive SPC plus FRESH, a 6-session (10-15 minutes each) multimedia intervention delivered via smartphone over 3 months to reduce HIV-related and intersectional stigma and improve empowerment. |
| mHC + FRESH + SPC | Experimental | Behavioral: mHC + FRESH + SPCDescription: Participants receive SPC plus both mHC and FRESH interventions delivered via smartphone over 3 months. |
Who may qualify
- Ages
- 18 to 29 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Age 18-29 years
- Male sex at birth
- Self-identify as transgender woman/female spectrum
- HIV-negative (laboratory confirmed)
- Recent condomless sex
Key exclusion criteria (4 listed)
- Serious cognitive or psychiatric condition affecting consent
- Active suicidal ideation or major mental illness
- Medical contraindications to PrEP
- Enrolled in another HIV intervention study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobile Healthy Choices (mHC)+SPCIntervention: * Behavioral: Mobile Healthy Choices (mHC) * Behavioral: Standard PrEP Counseling (SPC) | Behavioural | mHC + SPC |
| FRESH + SPCIntervention: * Behavioral: FRESH (Finding Respect and Ending Stigma around HIV) * Behavioral: Standard PrEP Counseling (SPC) | Behavioural | FRESH + SPC |
| mHC + FRESH + SPCIntervention: * Behavioral: Mobile Healthy Choices (mHC) * Behavioral: FRESH * Behavioral: Standard PrEP Counseling (SPC) | Behavioural | mHC + FRESH + SPC |
Primary outcome
HIV-related stigma score
Time frame: Baseline, Month 3, Month 6
HIV-related stigma (including internalized, perceived, anticipated, and enacted stigma) will be assessed using validated stigma scales. Higher scores indicate greater stigma.
PrEP uptake
Time frame: Baseline through Month 6
Proportion of participants who initiate PrEP during the study period among those not on PrEP at baseline.
PrEP adherence
Time frame: Baseline, Month 3, Month 6
PrEP adherence will be assessed using: * Self-reported adherence (e.g., number of doses taken in past 7 or 30 days) * Tenofovir diphosphate (TFV-DP) levels from dried blood spots Higher levels indicate better adherence.
HIV testing uptake
Time frame: Baseline, Month 3, Month 6
Proportion of participants who complete HIV testing at each follow-up visit.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nittaya Phanuphak, MD,PhD. principal investigator
INSTITUTE OF HIV RESEARCH AND INNOVATION FOUNDATION
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile Healthy Choices (mHC)+SPC, FRESH + SPC and mHC + FRESH + SPC in people with HIV Prevention and HIV Related Stigma, run by Institute of HIV Research and Innovation Foundation, Thailand at 3 sites in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nittaya Phanuphak, MD,PhD. (6681 825 3544, nittaya.p@ihri.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HIV-related stigma score (time frame: Baseline, Month 3, Month 6). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2026.