Trial Outcomes & Findings for Keep It Up! 2.0: A Comparison of Two Online HIV Intervention Programs for Young Men Who Have Sex With Men (NCT NCT01836445)

From May 2013 to December 2015, 901 participants were recruited and enrolled from (1) community-based HIV testing organizations in Atlanta, Chicago, and New York; (2) local health department clinics in Chicago; (3) street outreach in Atlanta, Chicago, and New York; and (4) local and national advertising.

Participants were randomized after completing a baseline assessment and STI testing.

Only participants who were employed and answered the follow-up questions on employment are included in the analysis population.

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

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

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

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

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

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.

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

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).

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

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

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.

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

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).

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.

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.

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

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).

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

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

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

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

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

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

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.

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