NCT04021953

Brief Summary

The study is a pragmatic, randomized controlled trial design to evaluate an online video series developed by a community-based organization in Singapore for gay, bisexual and queer men. A total of 300 HIV-negative, gay, bisexual and queer men in Singapore aged 18 to 29 years old will be recruited with the assistance of the partner community-based organization (CBO), Action for AIDS Singapore. Recruitment will utilize both online and offline channels, and with the help of other CBOs in Singapore. Participants should also not have watched the video prior to their participation in this study, which will be ascertained through a questionnaire. Participants will subsequently be randomized into the intervention arm (n=150) and the control arm (n=150). The treatment group (n=150) will be assigned the intervention along with sexual health information via a pamphlet, while the control group (n=150) will be assigned only the sexual health information via a pamphlet. This will be conducted through block randomization.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 12, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 16, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

October 13, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 6, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 6, 2020

Completed
Last Updated

September 1, 2021

Status Verified

August 1, 2021

Enrollment Period

9 months

First QC Date

July 12, 2019

Last Update Submit

August 30, 2021

Conditions

Keywords

HIV TestingSTI TestingHomophobiaeHealthSingapore

Outcome Measures

Primary Outcomes (18)

  • Change in intention to test for HIV at 3 months

    Participants are asked: "How likely are you to get tested for HIV in the next three months?"; to which they may respond: 1. Extremely unlikely to get tested 2. Very unlikely to get tested 3. Somewhat unlikely to get tested 4. Somewhat likely to get tested 5. Very likely to get tested 6. Extremely likely to get tested

    3 months

  • Change in intention to test for HIV at 6 months

    Participants are asked: "How likely are you to get tested for HIV in the next three months?"; to which they may respond: 1. Extremely unlikely to get tested 2. Very unlikely to get tested 3. Somewhat unlikely to get tested 4. Somewhat likely to get tested 5. Very likely to get tested 6. Extremely likely to get tested

    6 months

  • Change in intention to test for Syphilis at 3 months

    Participants are asked: "How likely are you to get tested for Syphilis in the next three months?"; to which they may respond: 1. Extremely unlikely to get tested 2. Very unlikely to get tested 3. Somewhat unlikely to get tested 4. Somewhat likely to get tested 5. Very likely to get tested 6. Extremely likely to get tested

    3 months

  • Change in intention to test for Syphilis at 6 months

    Participants are asked: "How likely are you to get tested for Syphilis in the next three months?"; to which they may respond: 1. Extremely unlikely to get tested 2. Very unlikely to get tested 3. Somewhat unlikely to get tested 4. Somewhat likely to get tested 5. Very likely to get tested 6. Extremely likely to get tested

    6 months

  • Change in intention to test for Chlamydia and Gonorrhea at 3 months

    Participants are asked: "How likely are you to get tested for Chlamydia and Gonorrhea in the next three months?"; to which they may respond: 1. Extremely unlikely to get tested 2. Very unlikely to get tested 3. Somewhat unlikely to get tested 4. Somewhat likely to get tested 5. Very likely to get tested 6. Extremely likely to get tested

    3 months

  • Change in intention to test for Chlamydia and Gonorrhea at 6 months

    Participants are asked: "How likely are you to get tested for Chlamydia and Gonorrhea in the next three months?"; to which they may respond: 1. Extremely unlikely to get tested 2. Very unlikely to get tested 3. Somewhat unlikely to get tested 4. Somewhat likely to get tested 5. Very likely to get tested 6. Extremely likely to get tested

    6 months

  • HIV testing at 3 months

    Participants are asked: "When did you go for you last (most recent) voluntary HIV test?"; to which they may respond: 1. Never 2. In the last 3 months 3. In the last 6 months 4. 6 to 12 months ago 5. More than 1 year ago

    3 months

  • HIV testing at 6 months

    Participants are asked: "When did you go for you last (most recent) voluntary HIV test?"; to which they may respond: 1. Never 2. In the last 3 months 3. In the last 6 months 4. 6 to 12 months ago 5. More than 1 year ago

    6 months

  • Syphilis testing at 3 months

    Participants are asked: "When did you go for you last (most recent) voluntary Syphilis test?"; to which they may respond: 1. Never 2. In the last 3 months 3. In the last 6 months 4. 6 to 12 months ago 5. More than 1 year ago

    3 months

  • Syphilis testing at 6 months

    Participants are asked: "When did you go for you last (most recent) voluntary Syphilis test?"; to which they may respond: 1. Never 2. In the last 3 months 3. In the last 6 months 4. 6 to 12 months ago 5. More than 1 year ago

    6 months

  • Chlamydia and Gonorrhea testing at 3 months

    Participants are asked: "When did you go for you last (most recent) voluntary Chlamydia or Gonorrhea test?"; to which they may respond: 1. Never 2. In the last 3 months 3. In the last 6 months 4. 6 to 12 months ago 5. More than 1 year ago

    3 months

  • Chlamydia and Gonorrhea testing at 6 months

    Participants are asked: "When did you go for you last (most recent) voluntary Chlamydia or Gonorrhea test?"; to which they may respond: 1. Never 2. In the last 3 months 3. In the last 6 months 4. 6 to 12 months ago 5. More than 1 year ago

    6 months

  • Self-reported regularity of HIV testing at 3 months

    Participants are asked: "On average, how regularly do you test for HIV?"; to which they may respond: 1. I do not test regularly 2. Once every few years 3. Once a year 4. Once every 6 months 5. Once every 3 months 6. Once a month

    3 months

  • Self-reported regularity of HIV testing at 6 months

    Participants are asked: "On average, how regularly do you test for HIV?"; to which they may respond: 1. I do not test regularly 2. Once every few years 3. Once a year 4. Once every 6 months 5. Once every 3 months 6. Once a month

    6 months

  • Self-reported regularity of Syphilis testing at 3 months

    Participants are asked: "On average, how regularly do you test for Syphilis?"; to which they may respond: 1. I do not test regularly 2. Once every few years 3. Once a year 4. Once every 6 months 5. Once every 3 months 6. Once a month

    3 months

  • Self-reported regularity of Syphilis testing at 6 months

    Participants are asked: "On average, how regularly do you test for Syphilis?"; to which they may respond: 1. I do not test regularly 2. Once every few years 3. Once a year 4. Once every 6 months 5. Once every 3 months 6. Once a month

    6 months

  • Self-reported regularity of Chlamydia and Gonorrhea testing at 3 months

    Participants are asked: "On average, how regularly do you test for Chlamydia and Gonorrhea?"; to which they may respond: 1. I do not test regularly 2. Once every few years 3. Once a year 4. Once every 6 months 5. Once every 3 months 6. Once a month

    3 months

  • Self-reported regularity of Chlamydia and Gonorrhea testing at 6 months

    Participants are asked: "On average, how regularly do you test for Chlamydia and Gonorrhea?"; to which they may respond: 1. I do not test regularly 2. Once every few years 3. Once a year 4. Once every 6 months 5. Once every 3 months 6. Once a month

    6 months

Secondary Outcomes (13)

  • Risk perception for HIV

    3 months and 6 months

  • Risk perception for other sexually transmitted infections

    3 months and 6 months

  • Knowledge of HIV Pre-Exposure Prophylaxis

    3 months and 6 months

  • Knowledge of risks associated with acquiring other sexually transmitted infections

    3 months and 6 months

  • Knowledge of HIV

    3 months and 6 months

  • +8 more secondary outcomes

Study Arms (2)

Intervention Group

EXPERIMENTAL

The online intervention comprises a series of six videos, each about 10-minutes in length, entitled the People Like Us series. The intervention was developed by gayhealth.sg and Action for AIDS Singapore in 2018. The series follow the love and sex lives of four ethnically-diverse GBQ men of varying socioeconomic backgrounds, as they negotiate issues of sexual health, mental health, and relationships throughout the six-part miniseries. The intervention group will also be provided with an e-pamphlet on sexual wellness catered to GBMSM. This e-pamphlet has been developed by the National Skin Centre and Department of Sexually Transmitted Infections Clinic specifically for information on sexual wellness among GBMSM. It comprises segments on HIV/STI symptoms, etiology, information on how to seek help for HIV/STI, behavioral and biomedical methods of HIV prevention.

Behavioral: People Like Us Online Video Series InterventionBehavioral: Sexual Health Pamphlet (Standard of Care)

Control Group

ACTIVE COMPARATOR

The control group will be provided with an e-pamphlet on sexual wellness catered to GBMSM. This e-pamphlet has been developed by the National Skin Centre and Department of Sexually Transmitted Infections Clinic specifically for information on sexual wellness among GBMSM. It comprises segments on HIV/STI symptoms, etiology, information on how to seek help for HIV/STI, behavioral and biomedical methods of HIV prevention.

Behavioral: Sexual Health Pamphlet (Standard of Care)

Interventions

People Like Us miniseries incorporates key sexual health messages to: 1. Increase viewers' knowledge and perceptions of HIV and other STI risk; 2. Address homophobia and sexual orientation disclosure; 3. Increase safer-sex negotiation self-efficacy; 4. Promote positive attitudes towards condom use and other safe sex behaviors; 5. Build skills and self-efficacy for practicing safer sex; 6. Provide information on HIV and other STI testing and its benefits; 7. Provide information on resources for HIV/STI testing and other mental health services; 8. Model appropriate behaviors around practicing safer sex. Each video in the six-part series ends with an educational video segment featuring the managers of Action for AIDS and Gayhealth.sg, who provide a brief synopsis of the episode and cover key points relevant to mental and sexual health for GBQ men.

Intervention Group

The control group will be provided with an e-pamphlet on sexual wellness catered to GBMSM. This e-pamphlet has been developed by the National Skin Centre and Department of Sexually Transmitted Infections Clinic specifically for information on sexual wellness among GBMSM. It comprises segments on HIV/STI symptoms, etiology, information on how to seek help for HIV/STI, behavioral and biomedical methods of HIV prevention.

Control GroupIntervention Group

Eligibility Criteria

Age18 Years - 29 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsSelf-identified Male gender (regardless of sex assigned at birth)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Self-reported HIV-negative status, or unsure of HIV status
  • Self-reported gay, bisexual or queer sexual orientation
  • Self-reported male gender, regardless of sex assigned at birth
  • Self-reported age of 18 to 29 years old at point of recruitment
  • Singapore citizen or permanent resident at the point of recruitment
  • Self-reported as never having watched an online video drama series by Gayhealth.sg or Action for AIDS in the last year

You may not qualify if:

  • Participants who have watched the People Like Us Series prior to study
  • Participants who have self-reported being HIV-positive
  • Participants who are not English-literate
  • Participants aged below 18 or above 29 at baseline recruitment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National University of Singapore

Singapore, Singapore

Location

Related Publications (2)

  • Tan RKJ, Koh WL, Le D, Banerjee S, Chio MT, Chan RKW, Wong CM, Tai BC, Wong ML, Cook AR, Chen MI, Wong CS. Effect of a Popular Web Drama Video Series on HIV and Other Sexually Transmitted Infection Testing Among Gay, Bisexual, and Other Men Who Have Sex With Men in Singapore: Community-Based, Pragmatic, Randomized Controlled Trial. J Med Internet Res. 2022 May 6;24(5):e31401. doi: 10.2196/31401.

  • Tan RKJ, Koh WL, Le D, Tan A, Tyler A, Tan C, Banerjee S, Wong CS, Wong ML, Chio MT, Chen MI. Effect of a web drama video series on HIV and other sexually transmitted infection testing among gay, bisexual and queer men: study protocol for a community-based, pragmatic randomised controlled trial in Singapore: the People Like Us (PLU) Evaluation Study. BMJ Open. 2020 Apr 7;10(4):e033855. doi: 10.1136/bmjopen-2019-033855.

MeSH Terms

Conditions

Acquired Immunodeficiency SyndromeSexually Transmitted DiseasesHomosexualityHealth BehaviorSocial StigmaPatient Acceptance of Health CareHomophobia

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsSexualitySexual BehaviorBehaviorSocial BehaviorTreatment Adherence and CompliancePrejudiceSocial Discrimination

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Rayner Kay Jin Tan, B.Soc.Sci

    National University of Singapore

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 12, 2019

First Posted

July 16, 2019

Study Start

October 13, 2019

Primary Completion

July 6, 2020

Study Completion

July 6, 2020

Last Updated

September 1, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations