HIV Self-Testing AND Uptake and Retention of PrEP Among Older Adolescent MSM and TGW

November 22, 2024 updated by: Thai Red Cross AIDS Research Centre

Study to Determine the Effect of HIV Self-testing on the Uptake of and Retention in Pre-exposure Prophylaxis Service Among Older Adolescent Men Who Have Sex With Men and Transgender Women

This will be a prospective study that will enroll up to 600 older adolescent MSM and TGW from community-based clinics in Bangkok, Chonburi, Chiang Mai, and Songkhla.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

All eligible participants will be followed up at month 3, 6, 9, and 12; month 6 and 12 will be mandatory clinic visits, while month 3 and 9 will be either clinic or a virtual visits. For participants accepting PrEP, additional follow-up visit at month 1, 2, 4, and 5 will be appointed; all visits will be either clinic or virtual visits.

Study Sites

The study will take place at the following community-based clinics:

  1. SWING DIC, Bangkok, Thailand
  2. RSAT DIC, Bangkok, Thailand
  3. SWING DIC, Chonburi, Thailand
  4. Sister DIC, Chonburi, Thailand
  5. Caremat DIC, Chiang Mai, Thailand
  6. MPlus DIC, Chiang Mai, Thailand
  7. RSAT DIC, Songkhla, Thailand

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Thailand
      • Bangkok, Thailand
        • 1.Swing Dic,
      • Bangkok,, Thailand
        • 2. Rsat Dic,
      • Chiang Mai, Thailand
        • 5. Caremat DIC,
      • Chiang Mai, Thailand
        • 6. MPlus DIC,
      • Chon Buri, Thailand
        • 3. Swing Dic,
      • Chon Buri, Thailand
        • 4. Sister DIC,
      • Songkhla, Thailand
        • 7. Rsat Dic,

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

15 years to 19 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Approximately 600 older adolescent MSM and TGW

Description

Inclusion Criteria:

  1. Thai nationality
  2. Age 15-19 years old
  3. Men or transgender women who have sex with men
  4. HIV-negative at the time of screening

  5. Have at least one of the following risks for HIV acquisition in the past 6 months:

    1. Any unprotected receptive anal sex with a male partner
    2. More than 5 male partners, regardless of condom use and serostatus
    3. Has had a bacterial sexually transmitted infection (STI)
    4. Any injected drug use
  6. Calculated creatinine clearance (CrCl) ≥ 75 mL/min, as estimated by the Cockcroft- Gault equation
  7. Alanine aminotransferase (ALT) ≤ 2.5 x ULN
  8. Have signed the informed consent form

Exclusion Criteria:

  1. HIV-positive
  2. Hepatitis B infection as indicated by positive hepatitis B surface antigen (HBsAg) test at time of screening
  3. Known allergy/sensitivity to tenofovir or emtricitabine

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Group 1
300 To determine the effect of HIVST on PrEP uptake among older adolescent MSM and TGW
Group 2
300 To determine the effect of HIVST on retention of older adolescent MSM and TGW in HIV service

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Proportion of participants starting PrEP among those who use and do not use HIVST
Time Frame: 3 years
3 years
Proportion of participants taking PrEP retaining in care among those who use and do not use HIVST
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Thai Red Cross AIDS Research Centre

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
United States Agency for International Development (USAID)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 15, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 15, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 26, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 14, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 14, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 19, 2018

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 26, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 22, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STANDUP-TEEN

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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