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Completed

NCT Number: NCT01836445

Keep It Up! 2.0: A Comparison of Two Online HIV Intervention Programs for Young Men Who Have Sex With Men

Young men who have sex with men (YMSM) account for almost 70% of HIV diagnoses among all young people in the U.S. and are alone in facing an increasing rate of infections. Because YMSM are less likely to receive relevant sexual health education in traditional settings (e.g. schools, community), the Internet is a unique route of reaching and helping YMSM.

The purpose of this study is to compare two different versions of an online HIV prevention program for YMSM. The study is being conducted by researchers at Northwestern University in Chicago, Hunter College in New York City, and Emory University in Atlanta. A total of 900 YMSM will be enrolled into this study from the clinics of community partners in Chicago, New York, and Atlanta.

Participants will be randomly assigned to one of two versions of the program. Some topics in the program include HIV facts and myths, sexually transmitted infections (STIs), and condom use. All participants, regardless of the program version they receive, will also take at-home urine and rectal tests for the STIs chlamydia and gonorrhea. After completing the program, participants will be contacted three more times over the course of a year for follow-up sessions and surveys.

The research team hypothesizes that the YMSM-specific prevention program will lead to a significant reduction in the frequency of unprotected anal sex acts and new STI infections compared to the HIV knowledge program that is for a general audience. The YMSM-specific program will also lead to improvements in secondary knowledge, motivation, and skills outcomes.

In order for the research team to measure the effectiveness of the YMSM-specific prevention program and determine if the study hypothesis is correct, participants will be asked questions about themselves, including questions about their sexual orientation, sexual experiences, health practices, including drug use, health knowledge, and questions about their feelings and emotions. Based on this information, the research team hopes to later change, improve, or expand the program to better address the needs of YMSM.

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Key information

Conditions

HIV Bacterial Infections Bacterial Infections and Mycoses Chlamydia Chlamydia Infections Chlamydiaceae Infections Communicable Diseases Genital Diseases Gonorrhea Gram-Negative Bacterial Infections Infections Neisseriaceae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Bacterial Urogenital Diseases

Age range

18 year–29 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Emory University, Atlanta, Georgia, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Birth male who identifies as male and reports sexual contact with another male
  • Received an HIV negative test result from a participating clinic/recruitment site
  • Unprotected anal sex with another male in the last 6 months
  • Ability to read English at 8th grade level

Exclusion criteria

  • HIV positive
  • Female or Transgender
  • No email address for contact
  • Currently in a monogamous relationship lasting longer than 6 months
  • Participated in previous versions of KIU!

Treatment and study plan

Keep It Up!

Behavioral

Other names: KIU!, KIU! 2.0, Keep It Up! 2.0

HIV Knowledge Control

Behavioral

Primary outcomes

  1. Participants Self-Reporting Condomless Anal Sex at Baseline and 3 Months

    Time frame: Baseline, 3 Months

    Change in self-report of condomless anal sex acts at three months.

  2. Participants Self-Reporting Condomless Anal Sex at Baseline and 6 Months

    Time frame: Baseline, 6 Months

    Change in self-report of condomless anal sex acts at six months.

  3. Participants Self-Reporting Condomless Anal Sex at Baseline and 12 Months

    Time frame: Baseline, 12 Months

    Change in self-report of condomless anal sex acts at twelve months.

  4. Number of Participants With Occurrence of Sexually Transmitted Infections (STIs) at Baseline

    Time frame: Baseline

    The incidence (number of new cases or diagnoses) of chlamydia and gonorrhea at baseline.

  5. Number of Participants With Occurrence of Sexually Transmitted Infections (STIs) at 12 Months

    Time frame: 12 months

    The incidence (number of new cases or diagnoses) of chlamydia and gonorrhea at twelve months.

Secondary outcomes

  1. Mean Score of Condom Errors at Baseline and 3 Months

    Time frame: Baseline, 3 Months

    The change in frequency that a participant has not correctly used a condom (for example, starting sex without a condom or using the wrong lube with condoms) at three months. Must have reported anal sex and using a condom with a partner at both time points. Range of scores - 0-11; higher scores = more errors.

  2. Percentage of Correct Responses on HIV Knowledge Assessment at Baseline and 3 Months

    Time frame: Baseline, 3 Months

    The change in number of HIV statements (e.g. "Only the receptive/bottom partner is at risk of being infected with HIV during anal sex", "There is a vaccine that can stop people from getting HIV", and "A natural skin (lamb skin) condom works better against HIV than does a latex condom") correctly labeled as true or false at three months. All 26 statements were recoded such that correct responses = 1 and incorrect or 'don't know' responses = 0. Composite scores were calculated to reflect the percentage of correct responses. Higher scores reflect greater knowledge of HIV transmission/risk.

  3. Mean Score of Motivation and Behavioral Skills at Baseline and 3 Months

    Time frame: Baseline, 3 Months

    At three months, the change in:

    • Motivation (for example, intentions to use condoms, perceived threat of HIV or STI infection, desire to become safer)
    • Social Norms (for example, partners, friends, or family members opinions about condom use)
    • Behavioral Skills (for example, negotiating condom use)

    Motivational Self-Rating - higher score = higher motivation; range 1-4 Social Norms - higher score = higher endorsement of social norms; range 1-5 Behavioral Skills - higher score = less perceived difficulty using condoms; range 1-4

  4. Mean Score of Health Protective Communication Skills at Baseline and 3 Months

    Time frame: Baseline, 3 Months

    The change in how frequently health protection (for example, condom use and regular HIV testing) is discussed with sex partners at three months. Higher score = less HPC skills; range 1-4 for each item on scale (relationship maintenance, condom use, and HIV testing).

  5. Number of Participants Reporting Drug Use Before Sex at Baseline and 12 Months

    Time frame: Baseline, 12 Month

    The change in number of participants who report using illegal drugs or drugs not prescribed by a doctor before sex.

  6. Mean Score of Condom Errors at Baseline and 6 Months

    Time frame: Baseline, 6 Months

    The change in frequency that a participant has not correctly used a condom (for example, starting sex without a condom or using the wrong lube with condoms) at six months. Must have reported anal sex and using a condom with a partner at both time points. Range of scores - 0-11; higher scores = more errors

  7. Percentage of Correct Responses on HIV Knowledge Assessment at Baseline and 6 Months

    Time frame: Baseline, 6 Months

    The change in number of HIV statements (e.g. "Only the receptive/bottom partner is at risk of being infected with HIV during anal sex", "There is a vaccine that can stop people from getting HIV", and "A natural skin (lamb skin) condom works better against HIV than does a latex condom") correctly labeled as true or false at six months. All 26 statements were recoded such that correct responses = 1 and incorrect or 'don't know' responses = 0. Composite scores were calculated to reflect the percentage of correct responses. Higher scores reflect greater knowledge of HIV transmission/risk.

  8. Mean Score of Motivation and Behavioral Skills at Baseline and 6 Months

    Time frame: Baseline, 6 Months

    At six months, the change in:

    • Motivation (for example, intentions to use condoms, perceived threat of HIV or STI infection, desire to become safer)
    • Social Norms (for example, partners, friends, or family members opinions about condom use)
    • Behavioral Skills (for example, negotiating condom use)

    Motivational Self-Rating - higher score = higher motivation; range 1-4 Social Norms - higher score = higher endorsement of social norms; range 1-5 Behavioral Skills - higher score = less perceived difficulty using condoms; range 1-4

  9. Mean Score of Health Protective Communication Skills at Baseline and 6 Months

    Time frame: Baseline, 6 Months

    The change in how frequently health protection (for example, condom use and regular HIV testing) is discussed with sex partners at six months. Higher score = less HPC skills; range 1-4 for each item on scale (relationship maintenance, condom use, and HIV testing).

  10. Mean Score of Condom Errors at Baseline and 12 Months

    Time frame: Baseline, 12 Months

    The change in frequency that a participant has not correctly used a condom (for example, starting sex without a condom or using the wrong lube with condoms) at twelve months. Must have reported anal sex and using a condom with a partner at both time points. Range of scores - 0-11; higher scores = more errors.

  11. Percentage of Correct Responses on HIV Knowledge Assessment at Baseline and 12 Months

    Time frame: Baseline, 12 Months

    The change in number of HIV statements (e.g. "Only the receptive/bottom partner is at risk of being infected with HIV during anal sex", "There is a vaccine that can stop people from getting HIV", and "A natural skin (lamb skin) condom works better against HIV than does a latex condom") correctly labeled as true or false at twelve months. All 26 statements were recoded such that correct responses = 1 and incorrect or 'don't know' responses = 0. Composite scores were calculated to reflect the percentage of correct responses. Higher scores reflect greater knowledge of HIV transmission/risk.

  12. Mean Score of Motivation and Behavioral Skills at Baseline and 12 Months

    Time frame: Baseline, 12 Months

    At twelve months, the change in:

    • Motivation (for example, intentions to use condoms, perceived threat of HIV or STI infection, desire to become safer)
    • Social Norms (for example, partners, friends, or family members opinions about condom use)
    • Behavioral Skills (for example, negotiating condom use)

    Motivational Self-Rating - higher score = higher motivation; range 1-4 Social Norms - higher score = higher endorsement of social norms; range 1-5 Behavioral Skills - higher score = less perceived difficulty using condoms; range 1-4

  13. Mean Score of Health Protective Communication Skills at Baseline and 12 Months

    Time frame: Baseline, 12 Months

    The change in how frequently health protection (for example, condom use and regular HIV testing) is discussed with sex partners at twelve months. Higher score = less HPC skills; range 1-4 for each item on scale (relationship maintenance, condom use, and HIV testing).

  14. Mean Score of Feelings of HIV Invulnerability at Baseline and 12 Months

    Time frame: Baseline, 12 Months

    The change in effect that HIV testing has on health beliefs (for example, "I cannot get HIV") and sexual behaviors at twelve months. Range 1-5; higher scores = more feelings of invulnerability

Other outcomes

  1. Participant Rating of Intervention Acceptability and Tolerability

    Time frame: Immediately following completion of intervention (up to 3 weeks after intervention is started by participant)

    Participant rating of how much they enjoyed the intervention and participant feedback and suggestions for improvement. Range 1-4; higher scores indicate greater acceptability.

  2. Participant Location

    Time frame: Immediately following completion of intervention (up to 3 weeks after intervention is started by participant)

    Log of where participants completed the intervention sessions (participants can select multiple locations).

  3. Participant Experiences of Harm at 3 Month Follow-up

    Time frame: 3 Months

    Log of any negative experiences or harm experienced by participant at three months.

  4. Participant Experiences of Harm at 6 Month Follow-up

    Time frame: 6 Months

    Log of any negative experiences or harm experienced by participant at six months.

  5. Participant Experiences of Harm at 12 Month Follow-up

    Time frame: 12 Months

    Log of any negative experiences or harm experienced by participant at twelve months.

  6. Occurrence of Sexually Transmitted Infections (STIs) at 3 Months

    Time frame: 3 Months

    The incidence (number of new cases or diagnoses) of chlamydia and gonorrhea at 3 month follow-up. Only measured for participants who initially tested positive for chlamydia or gonorrhea at baseline.

  7. Occurrence of Sexually Transmitted Infections (STIs) at 6 Months

    Time frame: 6 Months

    The incidence (number of new cases or diagnoses) of chlamydia and gonorrhea at 6 month follow-up. Only measured for participants who initially tested positive for chlamydia or gonorrhea at baseline.

  8. Level of Privacy

    Time frame: Immediately following completion of intervention (up to 3 weeks after intervention is started by participant)

    Log of the levels of privacy of the locations where participants completed intervention.

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Collaborators

  • Emory University
  • Hunter College of City University of New York
  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

Efficacy of Internet-based HIV Prevention

Acronym: KIU!

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Apr 19, 2013
Registry last updated
Aug 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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