Social Network StrategyNCT04953858
SNS to Increase HIV Testing Uptake and Linkage to Double Cascade Services Among Adolescent MSM and TGW in Thailand
A study testing Social network strategy (SNS) in people with Social Network Strategy and HIV Self Testing, run by Chulalongkorn University at 1 site in Thailand.
Trial summary
UNAIDS aims to end AIDS by 2030 using "90-90-90" diagnosis-treatment-viral suppression targets. Thailand has achieved elimination of HIV mother-to-child transmission, but continues to see new infections among adolescent men who have sex with men (YMSM) and transgender women (YTGW). Read more about this study
- Who is it for?
- Ages 15 to 24 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Social Network Strategy, HIV Self Testing, Men Who Have Sex With Men
- What is being tested?
- Social network strategy (SNS)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 202 participants
- Where
- 1 siteThailand
- Study dates
- 1 Apr 2021to 31 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 15 to 24 years
- Men only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- ages 15-24 years
- assigned male gender at birth
- self-defined gender identity of either MSM or TGW
- any one of the following: living with HIV, using HIV pre-exposure prophylaxis, receiving intermittent HIV testing for ongoing HIV risk
- good rapport with King Chulalongkorn Memorial Hospital (KCMH) Adolescent Health Clinic, knowledgable on HIV and comfortable discussing HIV with peers
- Network Members
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- ages 15-24 years
- assigned male gender at birth
- self-defined gender identity of either MSM or TGW
- self-reported oral and/or anal sex with a man in the past 12 months and at risk of HIV infection (multiple sex partners in the preceding 6 months and/or inconsistent condom use)
- no history of HIV testing or last HIV test > 3 months prior to study entry
Who cannot join
- Known to be living with HIV
Trial locations and contacts
1 site in 1 country.
Thailand1 site
The Division of Infectious Diseases, Department of Pediatrics, Faculty of Medicine, Chulalongkorn University
Bangkok
About this study
Official title: Social Network Strategy to Promote HIV Testing and Linkage to HIV Services Among Young Men Who Have Sex With Men and Transgender Women in Thailand
UNAIDS aims to end AIDS by 2030 using "90-90-90" diagnosis-treatment-viral suppression targets. Thailand has achieved elimination of HIV mother-to-child transmission, but continues to see new infections among adolescent men who have sex with men (YMSM) and transgender women (YTGW). Reaching and engagement of key populations to HIV services remains a major challenge, with differentiated care needed to address this. Investigators propose a study on outreach for HIV at-risk adolescents using peer-led social network strategies (SNS), linkage to facility-based HIV self-testing, and same day HIV prevention or treatment. The study will focus on the 15-19 year age group who have the highest HIV incidence in Thailand (6.9-10 per 100 person years, PY), but will also include young adults aged 20- 24 years of age, due to their frequently intertwining sex networks and very similar HIV incidence of 4.9-7.2 per 100 PY.
Eight hundred adolescent and young adult (AYA) MSM and TGW aged between 15-24 years will be recruited into a double HIV cascade care system. AYA aged between 15-24 years will be trained as recruiters to approach and refer their peers, 'network members' (NMs) to our adolescent clinic. NMs will be offered a choice of either blood-based or oral fluid-based HIV self-testing. HIV positive cases will be offered same-day antiretroviral therapy (SDART) and high-risk adolescents will be offered same day preexposure prophylaxis (PrEP). The project will be conducted at adolescent differentiated care services previously established by CIPHER grants in Thailand, located at King Chulalongkorn Memorial Hospital (KCMH), Bangkok. It will inform both Thailand and other Asia-Pacific region countries with similar epidemic patterns through an implementation research lens on strategies to engage YMSM and YTGW into HIV services, which investigators believe will make high-impact contributions to our collective ultimate goal of ending AIDS.
- Being tested
- Social network strategy (SNS)
- Medical subject headings
- Homosexuality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Social network strategy (SNS)Other
SNS utilizes peers to reach and recruit their network members into HIV services, therefore having the advantage that recruiters with different behavioral risks and HIV statuses are likely to have access to a wide variety of HIV at risk populations
| Study group | Role | What they receive |
|---|---|---|
| Social Network Strategy | Other | All study participants will receive social network strategy intervention as linkage method to receive HIV testing and care Receives: Other: Social network strategy (SNS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effectiveness of using social network strategies to increase HIV testing uptake in YMSM and YTGW.
Effectiveness will be measured by proportion of first-time testers among participants enrolled, defined as number of first-time testers divided by total number enrolled. SNS strategies are considered effective when proportions exceed 50 percent. Descriptive statistics of first-time tester characteristics, HIV risk factors, and their recruiter's characteristics will be described.
Measured: 24 months
Secondary outcomes (2)
Pre-exposure prophylaxis (PrEP) uptake among HIV negative at-risk adolescents
PrEP uptake is defined as the number of participants agreeing to initiate PrEP divided by the total number of HIV negative participants enrolled and association of PrEP uptake with factors include recruiter's characteristics will be evaluated utilizing logistic regression to calculate odd ratios and 95 percent confident intervals.
Measured: 24 months
Viral suppression at 6 months for those initiated on antiretroviral treatment among newly diagnosed HIV positive adolescents
Proportions of viral suppression seen at 6 months for those initiated on antiretroviral treatment among newly diagnosed HIV positive adolescents will be calculated. Descriptive statistics will used to describe this group of the sample. Comparison of characteristics between those viral suppressed and not virally suppressed will be performed.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2021
- Study start1 Apr 2021
- Primary completion31 Mar 2022
- Study completion31 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Social Network StrategyStudies of the same condition, open and under way.
- More trials run by Chulalongkorn UniversityThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Potential recruiters will be approached in routine adolescent HIV treatment and services and those enrolled will approach peers to become network members who then come in for HIV testing
- Masking
- None (open label)
- Enrolment
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04953858
- Sponsor's protocol ID
- SNS project
- Status last verified
- Apr 2021
- First submitted
- 4 May 2021
- Last updated
- 11 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Social Network Strategy to Promote HIV Testing and Linkage to HIV Services Among Young Men Who Have Sex With Men and Transgender Women in Thailand
- ClinicalTrials.gov ID
- NCT04953858
- Acronym / sponsor ID
- SNS project
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 8 Jul 2021 (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.
UNAIDS aims to end AIDS by 2030 using "90-90-90" diagnosis-treatment-viral suppression targets. Thailand has achieved elimination of HIV mother-to-child transmission, but continues to see new infections among adolescent men who have sex with men (YMSM) and transgender women (YTGW). Reaching and engagement of key populations to HIV services remains a major challenge, with differentiated care needed to address this. Investigators propose a study on outreach for HIV at-risk adolescents using peer-led social network strategies (SNS), linkage to facility-based HIV self-testing, and same day HIV prevention or treatment. The study will focus on the 15-19 year age group who have the highest HIV incidence in Thailand (6.9-10 per 100 person years, PY), but will also include young adults aged 20- 24 years of age, due to their frequently intertwining sex networks and very similar HIV incidence of 4.9-7.2 per 100 PY.
Eight hundred adolescent and young adult (AYA) MSM and TGW aged between 15-24 years will be recruited into a double HIV cascade care system. AYA aged between 15-24 years will be trained as recruiters to approach and refer their peers, 'network members' (NMs) to our adolescent clinic. NMs will be offered a choice of either blood-based or oral fluid-based HIV self-testing. HIV positive cases will be offered same-day antiretroviral therapy (SDART) and high-risk adolescents will be offered same day preexposure prophylaxis (PrEP). The project will be conducted at adolescent differentiated care services previously established by CIPHER grants in Thailand, located at King Chulalongkorn Memorial Hospital (KCMH), Bangkok. It will inform both Thailand and other Asia-Pacific region countries with similar epidemic patterns through an implementation research lens on strategies to engage YMSM and YTGW into HIV services, which investigators believe will make high-impact contributions to our collective ultimate goal of ending AIDS.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Potential recruiters will be approached in routine adolescent HIV treatment and services and those enrolled will approach peers to become network members who then come in for HIV testing
| Arm | Type | Receives |
|---|---|---|
| Social Network Strategy | Other | Other: Social network strategy (SNS)All study participants will receive social network strategy intervention as linkage method to receive HIV testing and care |
Who may qualify
- Ages
- 15 to 24 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (11 listed)
- ages 15-24 years
- assigned male gender at birth
- self-defined gender identity of either MSM or TGW
- any one of the following: living with HIV, using HIV pre-exposure prophylaxis, receiving intermittent HIV testing for ongoing HIV risk
- good rapport with King Chulalongkorn Memorial Hospital (KCMH) Adolescent Health Clinic, knowledgable on HIV and comfortable discussing HIV with peers
Key exclusion criteria (1 listed)
- Known to be living with HIV
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 |
|---|---|---|
| Social network strategy (SNS)SNS utilizes peers to reach and recruit their network members into HIV services, therefore having the advantage that recruiters with different behavioral risks and HIV statuses are likely to have access to a wide variety of HIV at risk populations | Other | Social Network Strategy |
Primary outcome
The effectiveness of using social network strategies to increase HIV testing uptake in YMSM and YTGW.
Time frame: 24 months
Effectiveness will be measured by proportion of first-time testers among participants enrolled, defined as number of first-time testers divided by total number enrolled. SNS strategies are considered effective when proportions exceed 50 percent. Descriptive statistics of first-time tester characteristics, HIV risk factors, and their recruiter's characteristics will be described.
2 secondary outcomes
Pre-exposure prophylaxis (PrEP) uptake among HIV negative at-risk adolescents
Time frame: 24 months
Viral suppression at 6 months for those initiated on antiretroviral treatment among newly diagnosed HIV positive adolescents
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2023.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Social network strategy (SNS) in people with Social Network Strategy and HIV Self Testing, run by Chulalongkorn University at 1 site 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 11 inclusion and 1 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: finished, as of the sponsor's last update on 11 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effectiveness of using social network strategies to increase HIV testing uptake in YMSM and YTGW. (time frame: 24 months). 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 11 Sep 2023.