The People Like Us Evaluation Study

Study Overview
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Brief Summary
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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.

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

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

Intervention / Treatment
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* Behavioral: People Like Us Online Video Series Intervention
* Behavioral: Sexual Health Pamphlet (Standard of Care)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 29 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br>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 Intervention<br>* 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.<br>Behavioral: Sexual Health Pamphlet (Standard of Care)<br>* 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.<br>|
| Active Comparator: Control Group<br>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)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Singapore, HIV Testing, STI Testing, Homophobia, eHealth