Clinical trial NCT03745495: HIV Self-Testing AND Uptake and Retention of PrEP Among Older Adolescent MSM and TGW
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Men or Transgender Women Who Have Sex With Men
Lead sponsor: Thai Red Cross AIDS Research Centre
Sponsor class: OTHER
Collaborators: name: United States Agency for International Development (USAID)
First posted: 2018-11-19
Enrollment: 600
Sex: MALE
Minimum age (years): 15
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Approximately 600 older adolescent MSM and TGW

Brief summary: 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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of participants starting PrEP among those who use and do not use HIVST
timeFrame: 3 years
measure: Proportion of participants taking PrEP retaining in care among those who use and do not use HIVST
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Bangkok,
country: Thailand
facility: 2. Rsat Dic,
city: Bangkok
country: Thailand
facility: 1.Swing Dic,
city: Chiang Mai
country: Thailand
facility: 5. Caremat DIC,
city: Chiang Mai
country: Thailand
facility: 6. MPlus DIC,
city: Chon Buri
country: Thailand
facility: 3. Swing Dic,
city: Chon Buri
country: Thailand
facility: 4. Sister DIC,
city: Songkhla
country: Thailand
facility: 7. Rsat Dic,
Study officials:
References: