Integrated Online-to-offline (O2O) Model of Care for HIV Prevention and Treatment Among Transgender Women (CINTAI)
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT06373965 |
Recruitment Status :
Not yet recruiting
First Posted : April 18, 2024
Last Update Posted : April 18, 2024
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Condition or disease | Intervention/treatment | Phase |
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HIV Prevention Program | Behavioral: Online to offline counseling | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 50 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | An Online HIV Self-testing Intervention With Online-to-offline Linkage to Care for Transgender Women |
Estimated Study Start Date : | May 19, 2024 |
Estimated Primary Completion Date : | January 6, 2025 |
Estimated Study Completion Date : | February 18, 2025 |
Arm | Intervention/treatment |
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Experimental: CINTAI
Participants randomized to the Jom-TestPlus group will have access to all Jom-TestPlus features, including: assessment center; online registration; risk calculator; HIVST kit order, management, and monitoring; automated reminders; real-time e-counseling (eHIVST, active referral services); chemsex-related harm reduction services (screening, chemsex e-counseling, PartyPack ordering), chat function (ability to chat with counselors and research staff); and knowledge center (multimedia library on information and resources on HIV testing, PrEP, treatment, risks, and chemsex). Participants will follow a defined pathway to accessing HIVST kit ordering, e-counseling, and subsequent O2O linkage to clinical services.
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Behavioral: Online to offline counseling
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Active Comparator: Control
The TAU group will have access to the assessment center (risk assessment, follow-up surveys), knowledge center (multimedia library on information and resources on HIV testing, PrEP, treatment, risks, and chemsex), and a voucher for no-cost community-based HIV testing (sent via secure, encrypted email or can be downloaded on the Jom-TestPlus).
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Behavioral: Online to offline counseling
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- HIVST uptake [ Time Frame: Time Frame: 3 and 6 months post-randomization ]Uptake of HIV self-testing (yes/no) will be assessed at each follow-up time point (3 and 6 months) using self-reported measure.
- Linkage to PrEP [ Time Frame: Time Frame: 3 and 6 months post-randomization ]Linked to PrEP (yes/no) will be assessed at each follow-up time point (3 and 6 months) using self-reported measure.
- Linkage to HIV treatment services [ Time Frame: Time Frame: 3 and 6 months post-randomization ]Linked to ART services (yes/no) will be assessed at each follow-up time point (3 and 6 months) using self-reported measure.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Age ≥18 years;
- Cisgender male;
- HIV-negative or HIV status unknown;
- Own or have access to a computer, tablet, or internet-enabled smartphone
Exclusion Criteria:
- Currently on PrEP
- Unable to provide informed consent
- Unable to read and understand English or Bahasa Malaysia
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06373965
Contact: Roman Shrestha | 8604862446 | roman.shrestha@uconn.edu |
Malaysia | |
Centre of Excellence For Research in AIDS (CERiA) | |
Kuala Lumpur, Malaysia |
Responsible Party: | Roman Shrestha, Assistant Professor, University of Connecticut |
ClinicalTrials.gov Identifier: | NCT06373965 |
Other Study ID Numbers: |
B2024-000 |
First Posted: | April 18, 2024 Key Record Dates |
Last Update Posted: | April 18, 2024 |
Last Verified: | April 2024 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
HIV transgender women |