- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04021953
The People Like Us Evaluation Study
Evaluation of eHealth Videos for the Singaporean Gay, Bisexual and Queer Male Community
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Singapore, Singapore
- National University of Singapore
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Intervention Group
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. |
People Like Us miniseries incorporates key sexual health messages to:
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.
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.
|
|
ACTIVE_COMPARATOR: Control 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in intention to test for HIV at 3 months
Time Frame: 3 months
|
Participants are asked: "How likely are you to get tested for HIV in the next three months?"; to which they may respond:
|
3 months
|
|
Change in intention to test for HIV at 6 months
Time Frame: 6 months
|
Participants are asked: "How likely are you to get tested for HIV in the next three months?"; to which they may respond:
|
6 months
|
|
Change in intention to test for Syphilis at 3 months
Time Frame: 3 months
|
Participants are asked: "How likely are you to get tested for Syphilis in the next three months?"; to which they may respond:
|
3 months
|
|
Change in intention to test for Syphilis at 6 months
Time Frame: 6 months
|
Participants are asked: "How likely are you to get tested for Syphilis in the next three months?"; to which they may respond:
|
6 months
|
|
Change in intention to test for Chlamydia and Gonorrhea at 3 months
Time Frame: 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:
|
3 months
|
|
Change in intention to test for Chlamydia and Gonorrhea at 6 months
Time Frame: 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:
|
6 months
|
|
HIV testing at 3 months
Time Frame: 3 months
|
Participants are asked: "When did you go for you last (most recent) voluntary HIV test?"; to which they may respond:
|
3 months
|
|
HIV testing at 6 months
Time Frame: 6 months
|
Participants are asked: "When did you go for you last (most recent) voluntary HIV test?"; to which they may respond:
|
6 months
|
|
Syphilis testing at 3 months
Time Frame: 3 months
|
Participants are asked: "When did you go for you last (most recent) voluntary Syphilis test?"; to which they may respond:
|
3 months
|
|
Syphilis testing at 6 months
Time Frame: 6 months
|
Participants are asked: "When did you go for you last (most recent) voluntary Syphilis test?"; to which they may respond:
|
6 months
|
|
Chlamydia and Gonorrhea testing at 3 months
Time Frame: 3 months
|
Participants are asked: "When did you go for you last (most recent) voluntary Chlamydia or Gonorrhea test?"; to which they may respond:
|
3 months
|
|
Chlamydia and Gonorrhea testing at 6 months
Time Frame: 6 months
|
Participants are asked: "When did you go for you last (most recent) voluntary Chlamydia or Gonorrhea test?"; to which they may respond:
|
6 months
|
|
Self-reported regularity of HIV testing at 3 months
Time Frame: 3 months
|
Participants are asked: "On average, how regularly do you test for HIV?"; to which they may respond:
|
3 months
|
|
Self-reported regularity of HIV testing at 6 months
Time Frame: 6 months
|
Participants are asked: "On average, how regularly do you test for HIV?"; to which they may respond:
|
6 months
|
|
Self-reported regularity of Syphilis testing at 3 months
Time Frame: 3 months
|
Participants are asked: "On average, how regularly do you test for Syphilis?"; to which they may respond:
|
3 months
|
|
Self-reported regularity of Syphilis testing at 6 months
Time Frame: 6 months
|
Participants are asked: "On average, how regularly do you test for Syphilis?"; to which they may respond:
|
6 months
|
|
Self-reported regularity of Chlamydia and Gonorrhea testing at 3 months
Time Frame: 3 months
|
Participants are asked: "On average, how regularly do you test for Chlamydia and Gonorrhea?"; to which they may respond:
|
3 months
|
|
Self-reported regularity of Chlamydia and Gonorrhea testing at 6 months
Time Frame: 6 months
|
Participants are asked: "On average, how regularly do you test for Chlamydia and Gonorrhea?"; to which they may respond:
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Risk perception for HIV
Time Frame: 3 months and 6 months
|
Risk perception is measures through a questions (slider scale) that asks participants: "How much risk do you think you are at of getting HIV?".
Participants will rate this from 0 to 10 (0=no risk at all; 10=very high risk)
|
3 months and 6 months
|
|
Risk perception for other sexually transmitted infections
Time Frame: 3 months and 6 months
|
Risk perception is measures through a questions (slider scale) that asks participants: "How much risk do you think you are at of getting other sexually transmitted infections?".
Participants will rate this from 0 to 10 (0=no risk at all; 10=very high risk)
|
3 months and 6 months
|
|
Knowledge of HIV Pre-Exposure Prophylaxis
Time Frame: 3 months and 6 months
|
Participants are tested on their knowledge of HIV Pre-Exposure Prophylaxis by providing a response (1=True; 2=False; 3=I do not know) to two questions: "HIV Pre-Exposure Prophylaxis is an effective means of preventing HIV infection". The correct answer is "True". "HIV Pre-Exposure Prophylaxis can also reduce the chances of acquiring other STIs". The correct answer is "False". Each correct answer provides a score of 1 point. |
3 months and 6 months
|
|
Knowledge of risks associated with acquiring other sexually transmitted infections
Time Frame: 3 months and 6 months
|
Participants are tested on their knowledge of other sexually transmitted infections by providing a response (1=True; 2=False; 3=I do not know) to three questions: "Gonorrhea can be transmitted through oral sex". The correct answer is "True". "Chemsex, or the use of substances during sex, often increases a person's risk of engaging in risky sexual behavior and acquiring HIV or other STIs" The correct answer is "True". "There is a/are clinics in Singapore where I can test anonymously for HIV and Syphilis". The correct answer is "True". Each correct answer provides a score of 1 point. |
3 months and 6 months
|
|
Knowledge of HIV
Time Frame: 3 months and 6 months
|
Participants are tested on their knowledge of HIV by providing a response (1=True; 2=False; 3=I do not know) to two questions: "An HIV-positive individual who has achieved viral suppression or an 'undetectable' viral load has almost zero chances of transmitting the virus to someone else through sexual intercourse". The correct answer is "True". "An HIV-positive individual on effective treatment can live a long, healthy, and productive life". The correct answer is "True". Each correct answer provides a score of 1 point. |
3 months and 6 months
|
|
Connectedness to LGBT Community
Time Frame: 3 months and 6 months
|
This is an 8-item scale adapted from Frost & Meyer (2012) that measures a participant's self-perceived connectedness to the LGBT community on a 4-point Likert Scale.
The measure is a sum score of all 8 items.
|
3 months and 6 months
|
|
Modified Self-Concealment Scale
Time Frame: 3 months and 6 months
|
This is a 7-item scale adapted from Scrimshaw (2013) that measures a participant's self-concealment of their sexual orientation on a 5-point Likert Scale.
The measure is a sum score of all 7 items.
|
3 months and 6 months
|
|
Consistent condom use for anal sex with casual partners or sex workers
Time Frame: 3 months and 6 months
|
This is assessed by the question, "In the last 3 months, how often did you use a condom when having anal sex with a casual partner?" or "In the last 3 months, how often did you use a condom when having anal sex with a sex worker/money boy?" (Options are always, more than half the time, about half the time, less than half the time, never used a condom).
Participants who give the answer 'Always' are classified as having consistent condom usage for anal sex with causal partners or sex workers.
|
3 months and 6 months
|
|
Incidence of sexually transmitted infections
Time Frame: 3 months and 6 months
|
This is defined as self-reporting a diagnosis of Syphilis, Chlamydia, Genital Herpes, Genital Warts, Hepatitis C, or Gonorrhea at the 3-month or 6-month follow-up.
|
3 months and 6 months
|
|
Perceived Homophobia
Time Frame: 3 months and 6 months
|
This is a 6-item scale adapted from Smolenski, Ross, Risser, and Rosser (2009) that measures a participant's self-concealment of their sexual orientation.
The measure is a sum score of all 6 items.
|
3 months and 6 months
|
|
Internalized Homophobia
Time Frame: 3 months and 6 months
|
This is a 5-item scale adapted from Frost and Meyer (2013) that measures a participant's internalized homophobia on a 4-point Likert Scale.
The measure is a sum score of all 5 items.
|
3 months and 6 months
|
|
HIV testing self-efficacy
Time Frame: 3 months and 6 months
|
This is a 10-item scale adapted from Jamil and colleagues (2015) that measures a participant's self-efficacy in HIV testing on a 5-point Likert Scale.
The measure is a sum score of all 10 items.
|
3 months and 6 months
|
|
HIV testing social norms
Time Frame: 3 months and 6 months
|
This is a 9-item scale adapted from Pettifor and colleagues (2010) that measures a participant's perceptions on norms around HIV testing on a 4-point Likert Scale.
The measure is a sum score of all 9 items.
|
3 months and 6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Rayner Kay Jin Tan, B.Soc.Sci, National University, Singapore
Publications and helpful links
General Publications
- 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.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- S-19-059
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on HIV/AIDS
-
University of MinnesotaWithdrawnHIV Infections | HIV/AIDS | Hiv | AIDS | Aids/Hiv Problem | AIDS and InfectionsUnited States
-
University of California, San DiegoNational Institute of Allergy and Infectious Diseases (NIAID)Completed
-
University of Massachusetts, BostonCompleted
-
Stanford UniversityJanssen Services, LLCCompleted
-
ViiV HealthcareJohns Hopkins University; Pfizer; Vanderbilt University; University of North Carolina...Completed
-
Medical College of WisconsinCompleted
-
Emory UniversityCompleted
-
Rhode Island HospitalUnknown
-
Tibotec Pharmaceuticals, IrelandCompleted
-
Lampiris, Harry W., M.D.AbbottUnknown
Clinical Trials on People Like Us Online Video Series Intervention
-
Universidad de ValparaisoPontificia Universidad Catolica de Chile; University of ChileCompleted
-
Case Comprehensive Cancer CenterNational Cancer Institute (NCI)CompletedSkin Carcinoma | Skin MelanomaUnited States
-
The Miriam HospitalUnknown
-
Fred Hutchinson Cancer CenterCompleted
-
North Essex Partnership NHS Foundation TrustUniversity College, London; West Essex Clinical Commissioning Group; School for...CompletedStroke | Diabetes Mellitus | Dementia | Mild Cognitive Impairment | Cardiac DiseasesUnited Kingdom
-
The Miriam HospitalCompleted