Combination Prevention Effectiveness Study for Young MSM

• Register: TCTR
• Last refreshed on: 29 April 2024
• Main ID: TCTR20170408001
• Date of registration: 08/04/2017
• Prospective Registration: Yes
• Primary sponsor: US National Institutes of Health (NIH)
• Public title: Combination Prevention Effectiveness Study for Young MSM
• Scientific title: Effectiveness and Cost Effectiveness of a Combination HIV Preventive Intervention with and without daily oral Truvada® pre-exposure prophylaxis (PrEP) with adherence support among young men who have sex with men (YMSM) and transgender women (TGW) ag
• Date of first enrolment: 10/10/2017
• Target sample size: 1240
• Recruitment status: Recruiting
• URL: https://www.thaiclinicaltrials.org/show/TCTR20170408001
• Study type: Interventional
• Study design: N/A
• Phase: N/A

Countries of recruitment

Thailand

Contacts

• Name: Pachara Sirivongrangson
• Affiliation: Department of Disease Control, Thailand Ministry of Public Health

• Name: Pachara Sirivongrangson
• Affiliation: Department of Disease Control, Thailand Ministry of Public Health

Key inclusion & exclusion criteria

Inclusion criteria: • Biological male sex at birth
• Self-report of having sold or traded sex to another man for money, drugs, or other goods or services in the previous 12 months.
• Age 18 through 26 years at enrollment
• Self-reported living in the greater Bangkok Metropolitan area or Pattaya City
• Willing to complete study instruments, with or without assistance, Thai and/or English.
• Thai citizenship
• Willing to provide contact and locator information
• Self-reported negative or unknown HIV status
• Negative rapid HIV test result at the screening visit

Exclusion criteria: • Unable or unwilling to provide consent for study participation
• Rapid HIV test results at the screening visit suggesting HIV infection
• Did not complete baseline assessment (Section 3.1 above)
• Any condition that would make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.
• Concurrently enrolled in another PrEP (oral or topical or injectable) intervention trial or preventive HIV vaccine trial.

Age minimum: 18 Years
Age maximum: 26 Years
Gender: Male

Health Condition(s) or Problem(s) studied

HIV Infection Prevention
HIV
Combination prevention
Young MSM
PrEP
Effectiveness
Cost-Effectiveness

HIV
Combination prevention
Young MSM
PrEP
Effectiveness
Cost-Effectiveness

Intervention(s)

Combination prevention intervention with and without PrEP

Sham Comparator Drug

an open label, non-randomized assessment of daily oral tenofovir/emtricitabine (Truvada®) pre-exposure prophylaxis (PrEP) with adherence support

Primary Outcome(s)

effectiveness of an open-label combination HIV preventive intervention within 12 months after PrEP initiation compare HIV incidence densities among participants with and without PrEP

Secondary Outcome(s)

Cost-Effectiveness of Combination prevention intervention with PrEP 2 year after last participant complete follow-up Assess the incremental costs associated with combined HIV prevention with PrEP use

Secondary ID(s)

1R01AI118505-01A1

Source(s) of Monetary Support

US National Institutes of Health (NIH)

Secondary Sponsor(s)

Ministry of Public Health (MOPH), Department of disease control

Ethics review

Status: Submitted, approved
Approval date:
Contact:

The Ethical Review Committee for Research in Human Subjects, Ministry of Public Health

02-590-6171 Ext.

Results

• Date Completed: 10/10/2020