The People Like Us Evaluation Study

Health Behavior Clinical Trial

Official title:

Evaluation of eHealth Videos for the Singaporean Gay, Bisexual and Queer Male Community

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04021953
• Other study ID #: S-19-059
• Status: Completed
• Phase: N/A
• Start date: October 13, 2019
• Est. completion date: July 6, 2020

Study information

• Verified date: August 2021
• Source: National University, Singapore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: July 6, 2020
• Est. primary completion date: July 6, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 29 Years

Eligibility

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

Related Conditions & MeSH terms

• Health Behavior
• Health Care Seeking Behavior
• HIV/AIDS
• Homosexuality
• Sexually Transmitted Diseases
• Sexually Transmitted Infection
• Stigma, Social

Intervention

Behavioral:
• People Like Us Online Video Series Intervention
People Like Us miniseries incorporates key sexual health messages to: Increase viewers' knowledge and perceptions of HIV and other STI risk; Address homophobia and sexual orientation disclosure; Increase safer-sex negotiation self-efficacy; Promote positive attitudes towards condom use and other safe sex behaviors; Build skills and self-efficacy for practicing safer sex; Provide information on HIV and other STI testing and its benefits; Provide information on resources for HIV/STI testing and other mental health services; 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.
• Sexual Health Pamphlet (Standard of Care)
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.

Locations

Country	Name	City	State
Singapore	National University of Singapore	Singapore

Sponsors (3)

Lead Sponsor	Collaborator
National University, Singapore	Action for AIDS Singapore, National Centre for Infectious Diseases, Singapore

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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: Extremely unlikely to get tested; Very unlikely to get tested; Somewhat unlikely to get tested; Somewhat likely to get tested; Very likely to get tested; Extremely likely to get tested	3 months
Primary	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: Extremely unlikely to get tested; Very unlikely to get tested; Somewhat unlikely to get tested; Somewhat likely to get tested; Very likely to get tested; Extremely likely to get tested	6 months
Primary	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: Extremely unlikely to get tested; Very unlikely to get tested; Somewhat unlikely to get tested; Somewhat likely to get tested; Very likely to get tested; Extremely likely to get tested	3 months
Primary	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: Extremely unlikely to get tested; Very unlikely to get tested; Somewhat unlikely to get tested; Somewhat likely to get tested; Very likely to get tested; Extremely likely to get tested	6 months
Primary	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: Extremely unlikely to get tested; Very unlikely to get tested; Somewhat unlikely to get tested; Somewhat likely to get tested; Very likely to get tested; Extremely likely to get tested	3 months
Primary	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: Extremely unlikely to get tested; Very unlikely to get tested; Somewhat unlikely to get tested; Somewhat likely to get tested; Very likely to get tested; Extremely likely to get tested	6 months
Primary	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: Never; In the last 3 months; In the last 6 months; 6 to 12 months ago; More than 1 year ago	3 months
Primary	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: Never; In the last 3 months; In the last 6 months; 6 to 12 months ago; More than 1 year ago	6 months
Primary	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: Never; In the last 3 months; In the last 6 months; 6 to 12 months ago; More than 1 year ago	3 months
Primary	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: Never; In the last 3 months; In the last 6 months; 6 to 12 months ago; More than 1 year ago	6 months
Primary	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: Never; In the last 3 months; In the last 6 months; 6 to 12 months ago; More than 1 year ago	3 months
Primary	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: Never; In the last 3 months; In the last 6 months; 6 to 12 months ago; More than 1 year ago	6 months
Primary	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: I do not test regularly; Once every few years; Once a year; Once every 6 months; Once every 3 months; Once a month	3 months
Primary	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: I do not test regularly; Once every few years; Once a year; Once every 6 months; Once every 3 months; Once a month	6 months
Primary	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: I do not test regularly; Once every few years; Once a year; Once every 6 months; Once every 3 months; Once a month	3 months
Primary	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: I do not test regularly; Once every few years; Once a year; Once every 6 months; Once every 3 months; Once a month	6 months
Primary	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: I do not test regularly; Once every few years; Once a year; Once every 6 months; Once every 3 months; Once a month	3 months
Primary	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: I do not test regularly; Once every few years; Once a year; Once every 6 months; Once every 3 months; Once a month	6 months
Secondary	Risk perception for HIV	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
Secondary	Risk perception for other sexually transmitted infections	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
Secondary	Knowledge of HIV Pre-Exposure Prophylaxis	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
Secondary	Knowledge of risks associated with acquiring other sexually transmitted infections	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
Secondary	Knowledge of HIV	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
Secondary	Connectedness to LGBT Community	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
Secondary	Modified Self-Concealment Scale	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
Secondary	Consistent condom use for anal sex with casual partners or sex workers	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
Secondary	Incidence of sexually transmitted infections	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
Secondary	Perceived Homophobia	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
Secondary	Internalized Homophobia	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
Secondary	HIV testing self-efficacy	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
Secondary	HIV testing social norms	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