Trial Outcomes & Findings for Steering Together in a New Direction: Reducing the Risk of HIV/STD Among African American Men (NCT NCT02572401)
NCT ID: NCT02572401
Last Updated: 2019-10-15
Results Overview
A binary variable reflecting whether or not the participant reports using a condom every time he had vaginal or anal intercourse with a woman in the previous 3 months. It will be based on a comparison of the number of protected intercourse acts and the number of intercourse acts. Men who report at least one intercourse act and whose number of reported protected acts equals their number of acts use condoms during 100% of intercourse acts and will be defined as practicing consistent condom use. Men who report at least one intercourse act and whose reported number of protected acts is less than their number of acts will be coded as not practicing consistent condom use. Separate binary variables reflect consistent condom use with steady partners and casual partners analyzed as a repeated outcome.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
391 participants
Primary outcome timeframe
Baseline, 6 months, 12 months post-intervention
Results posted on
2019-10-15
Participant Flow
Participant milestones
| Measure |
HIV Risk Reduction Only
STAND HIV Risk Reduction Intervention. Participants will not receive the Text Messaging Intervention.
STAND HIV Risk Reduction Intervention: STAND HIV Risk Reduction Intervention, designed to increase consistent condom use and reduce other sexual risk behaviors, is implemented in small groups over 2 weekly 135-min sessions. It draws on social cognitive theory, the reasoned action approach, and focus groups, a prospective survey, and an intervention pilot test with African American men. It contains culturally appropriate video clips, interactive activities, brainstorming, role-playing, and discussions designed to affect hypothesized mediators of risk-reducing behavior, including outcome expectancies about the effects of condom use on sexual enjoyment; self-efficacy and skill to have condoms available and to stop to use condoms or refuse unsafe sex even when aroused; and self-efficacy and skill to negotiate condom use.
|
No-Intervention No-Text Message Control
Participants do not receive the STAND HIV Risk Reduction Intervention or the Text Messaging Intervention.
|
HIV Risk Reduction and Text Messaging
STAND HIV Risk Reduction Intervention and Text Messaging Intervention. Participants will receive the intervention and text messages.
STAND HIV Risk Reduction Intervention: STAND HIV Risk Reduction Intervention, designed to increase consistent condom use and reduce other sexual risk behaviors, is implemented in small groups over 2 weekly 135-min sessions. It draws on social cognitive theory, the reasoned action approach, and focus groups, a prospective survey, and an intervention pilot test with African American men. It contains culturally appropriate video clips, interactive activities, brainstorming, role-playing, and discussions designed to affect hypothesized mediators of risk-reducing behavior, including outcome expectancies about the effects of condom use on sexual enjoyment; self-efficacy and skill to have condoms available and to stop to use condoms or refuse unsafe sex even when aroused; and self-efficacy and skill to negotiate condom use.
Text Messaging Intervention:
|
Text Messaging Only
Text Messaging Intervention. Participants will receive the text messages but not the STAND HIV Risk Reduction Intervention.
Text Messaging Intervention: Text Messaging Intervention participants receive text messages designed to increase the consistent use of condoms and to reduce other sexual risk behaviors. They receive 3 times a week text messages that ask about their sexual behavior and condom use that day and are asked to respond with either a 1 or 2 numeric response to indicate yes or no. Based on their responses, they receive either an affirming, pro safe-sex text message or a cautionary text against unprotected sex.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
97
|
98
|
98
|
98
|
|
Overall Study
COMPLETED
|
92
|
90
|
89
|
88
|
|
Overall Study
NOT COMPLETED
|
5
|
8
|
9
|
10
|
Reasons for withdrawal
| Measure |
HIV Risk Reduction Only
STAND HIV Risk Reduction Intervention. Participants will not receive the Text Messaging Intervention.
STAND HIV Risk Reduction Intervention: STAND HIV Risk Reduction Intervention, designed to increase consistent condom use and reduce other sexual risk behaviors, is implemented in small groups over 2 weekly 135-min sessions. It draws on social cognitive theory, the reasoned action approach, and focus groups, a prospective survey, and an intervention pilot test with African American men. It contains culturally appropriate video clips, interactive activities, brainstorming, role-playing, and discussions designed to affect hypothesized mediators of risk-reducing behavior, including outcome expectancies about the effects of condom use on sexual enjoyment; self-efficacy and skill to have condoms available and to stop to use condoms or refuse unsafe sex even when aroused; and self-efficacy and skill to negotiate condom use.
|
No-Intervention No-Text Message Control
Participants do not receive the STAND HIV Risk Reduction Intervention or the Text Messaging Intervention.
|
HIV Risk Reduction and Text Messaging
STAND HIV Risk Reduction Intervention and Text Messaging Intervention. Participants will receive the intervention and text messages.
STAND HIV Risk Reduction Intervention: STAND HIV Risk Reduction Intervention, designed to increase consistent condom use and reduce other sexual risk behaviors, is implemented in small groups over 2 weekly 135-min sessions. It draws on social cognitive theory, the reasoned action approach, and focus groups, a prospective survey, and an intervention pilot test with African American men. It contains culturally appropriate video clips, interactive activities, brainstorming, role-playing, and discussions designed to affect hypothesized mediators of risk-reducing behavior, including outcome expectancies about the effects of condom use on sexual enjoyment; self-efficacy and skill to have condoms available and to stop to use condoms or refuse unsafe sex even when aroused; and self-efficacy and skill to negotiate condom use.
Text Messaging Intervention:
|
Text Messaging Only
Text Messaging Intervention. Participants will receive the text messages but not the STAND HIV Risk Reduction Intervention.
Text Messaging Intervention: Text Messaging Intervention participants receive text messages designed to increase the consistent use of condoms and to reduce other sexual risk behaviors. They receive 3 times a week text messages that ask about their sexual behavior and condom use that day and are asked to respond with either a 1 or 2 numeric response to indicate yes or no. Based on their responses, they receive either an affirming, pro safe-sex text message or a cautionary text against unprotected sex.
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
5
|
8
|
9
|
9
|
|
Overall Study
Death
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Steering Together in a New Direction: Reducing the Risk of HIV/STD Among African American Men
Baseline characteristics by cohort
| Measure |
HIV Risk Reduction Only
n=97 Participants
STAND HIV Risk Reduction Intervention. Participants will not receive the Text Messaging Intervention.
STAND HIV Risk Reduction Intervention: STAND HIV Risk Reduction Intervention, designed to increase consistent condom use and reduce other sexual risk behaviors, is implemented in small groups over 2 weekly 135-min sessions. It draws on social cognitive theory, the reasoned action approach, and focus groups, a prospective survey, and an intervention pilot test with African American men. It contains culturally appropriate video clips, interactive activities, brainstorming, role-playing, and discussions designed to affect hypothesized mediators of risk-reducing behavior, including outcome expectancies about the effects of condom use on sexual enjoyment; self-efficacy and skill to have condoms available and to stop to use condoms or refuse unsafe sex even when aroused; and self-efficacy and skill to negotiate condom use.
|
No-Intervention No-Text Message Control
n=98 Participants
Participants do not receive the STAND HIV Risk Reduction Intervention or the Text Messaging Intervention.
|
HIV Risk Reduction and Text Messaging
n=98 Participants
STAND HIV Risk Reduction Intervention and Text Messaging Intervention. Participants will receive the intervention and text messages.
STAND HIV Risk Reduction Intervention: STAND HIV Risk Reduction Intervention, designed to increase consistent condom use and reduce other sexual risk behaviors, is implemented in small groups over 2 weekly 135-min sessions. It draws on social cognitive theory, the reasoned action approach, and focus groups, a prospective survey, and an intervention pilot test with African American men. It contains culturally appropriate video clips, interactive activities, brainstorming, role-playing, and discussions designed to affect hypothesized mediators of risk-reducing behavior, including outcome expectancies about the effects of condom use on sexual enjoyment; self-efficacy and skill to have condoms available and to stop to use condoms or refuse unsafe sex even when aroused; and self-efficacy and skill to negotiate condom use.
Text Messaging Intervention:
|
Text Messaging Only
n=98 Participants
Text Messaging Intervention. Participants will receive the text messages but not the STAND HIV Risk Reduction Intervention.
Text Messaging Intervention: Text Messaging Intervention participants receive text messages designed to increase the consistent use of condoms and to reduce other sexual risk behaviors. They receive 3 times a week text messages that ask about their sexual behavior and condom use that day and are asked to respond with either a 1 or 2 numeric response to indicate yes or no. Based on their responses, they receive either an affirming, pro safe-sex text message or a cautionary text against unprotected sex.
|
Total
n=391 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
97 Participants
n=5 Participants
|
98 Participants
n=7 Participants
|
98 Participants
n=5 Participants
|
98 Participants
n=4 Participants
|
391 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Continuous
|
27.18 years
STANDARD_DEVIATION 8.28 • n=5 Participants
|
27.65 years
STANDARD_DEVIATION 8.63 • n=7 Participants
|
27.73 years
STANDARD_DEVIATION 8.28 • n=5 Participants
|
28.42 years
STANDARD_DEVIATION 8.60 • n=4 Participants
|
27.75 years
STANDARD_DEVIATION 8.43 • n=21 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
97 Participants
n=5 Participants
|
98 Participants
n=7 Participants
|
98 Participants
n=5 Participants
|
98 Participants
n=4 Participants
|
391 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
95 Participants
n=5 Participants
|
95 Participants
n=7 Participants
|
94 Participants
n=5 Participants
|
96 Participants
n=4 Participants
|
380 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
95 Participants
n=5 Participants
|
94 Participants
n=7 Participants
|
94 Participants
n=5 Participants
|
95 Participants
n=4 Participants
|
378 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
97 participants
n=5 Participants
|
98 participants
n=7 Participants
|
98 participants
n=5 Participants
|
98 participants
n=4 Participants
|
391 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline, 6 months, 12 months post-interventionPopulation: Participants providing primary outcome data at baseline and at least one post-intervention assessment.
A binary variable reflecting whether or not the participant reports using a condom every time he had vaginal or anal intercourse with a woman in the previous 3 months. It will be based on a comparison of the number of protected intercourse acts and the number of intercourse acts. Men who report at least one intercourse act and whose number of reported protected acts equals their number of acts use condoms during 100% of intercourse acts and will be defined as practicing consistent condom use. Men who report at least one intercourse act and whose reported number of protected acts is less than their number of acts will be coded as not practicing consistent condom use. Separate binary variables reflect consistent condom use with steady partners and casual partners analyzed as a repeated outcome.
Outcome measures
| Measure |
HIV Risk Reduction Only
n=67 Participants
STAND HIV Risk Reduction Intervention. Participants will not receive the Text Messaging Intervention.
STAND HIV Risk Reduction Intervention: STAND HIV Risk Reduction Intervention, designed to increase consistent condom use and reduce other sexual risk behaviors, is implemented in small groups over 2 weekly 135-min sessions. It draws on social cognitive theory, the reasoned action approach, and focus groups, a prospective survey, and an intervention pilot test with African American men. It contains culturally appropriate video clips, interactive activities, brainstorming, role-playing, and discussions designed to affect hypothesized mediators of risk-reducing behavior, including outcome expectancies about the effects of condom use on sexual enjoyment; self-efficacy and skill to have condoms available and to stop to use condoms or refuse unsafe sex even when aroused; and self-efficacy and skill to negotiate condom use.
|
No-Intervention No-Text Message Control
n=56 Participants
Participants do not receive the STAND HIV Risk Reduction Intervention or the Text Messaging Intervention.
|
HIV Risk Reduction and Text Messaging
n=74 Participants
STAND HIV Risk Reduction Intervention and Text Messaging Intervention. Participants will receive the intervention and text messages.
STAND HIV Risk Reduction Intervention: STAND HIV Risk Reduction Intervention, designed to increase consistent condom use and reduce other sexual risk behaviors, is implemented in small groups over 2 weekly 135-min sessions. It draws on social cognitive theory, the reasoned action approach, and focus groups, a prospective survey, and an intervention pilot test with African American men. It contains culturally appropriate video clips, interactive activities, brainstorming, role-playing, and discussions designed to affect hypothesized mediators of risk-reducing behavior, including outcome expectancies about the effects of condom use on sexual enjoyment; self-efficacy and skill to have condoms available and to stop to use condoms or refuse unsafe sex even when aroused; and self-efficacy and skill to negotiate condom use.
Text Messaging Intervention:
|
Text Messaging Only
n=71 Participants
Text Messaging Intervention. Participants will receive the text messages but not the STAND HIV Risk Reduction Intervention.
Text Messaging Intervention: Text Messaging Intervention participants receive text messages designed to increase the consistent use of condoms and to reduce other sexual risk behaviors. They receive 3 times a week text messages that ask about their sexual behavior and condom use that day and are asked to respond with either a 1 or 2 numeric response to indicate yes or no. Based on their responses, they receive either an affirming, pro safe-sex text message or a cautionary text against unprotected sex.
|
|---|---|---|---|---|
|
Consistent (100%) Condom Use
Baseline steady partners
|
9 Participants
|
6 Participants
|
7 Participants
|
7 Participants
|
|
Consistent (100%) Condom Use
6 mo steady partners
|
6 Participants
|
5 Participants
|
8 Participants
|
9 Participants
|
|
Consistent (100%) Condom Use
12 mo steady partners
|
10 Participants
|
5 Participants
|
12 Participants
|
11 Participants
|
|
Consistent (100%) Condom Use
Baseline casual partners
|
26 Participants
|
12 Participants
|
27 Participants
|
15 Participants
|
|
Consistent (100%) Condom Use
6 mo casual partners
|
13 Participants
|
12 Participants
|
13 Participants
|
17 Participants
|
|
Consistent (100%) Condom Use
12 mo casual partners
|
11 Participants
|
13 Participants
|
16 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: Baseline, 6 months, 12 months post-interventionPopulation: Participants providing the outcome measure at baseline and at least one post-intervention assessment.
A binary variable indicating whether the participants reported having intercourse in the past 90 days without using a condom. It was constructed by subtracting the sum of the condom-protected intercourse acts from the total number of intercourse acts in the past 90 days. If the difference was one or greater the participant was coded as having unprotected intercourse; if the difference was zero or if the person reported no intercourse in the past 90 days, the person was coded as not having unprotected intercourse. Calculated separately for steady partners and casual partners and analyzed as a repeated outcome.
Outcome measures
| Measure |
HIV Risk Reduction Only
n=90 Participants
STAND HIV Risk Reduction Intervention. Participants will not receive the Text Messaging Intervention.
STAND HIV Risk Reduction Intervention: STAND HIV Risk Reduction Intervention, designed to increase consistent condom use and reduce other sexual risk behaviors, is implemented in small groups over 2 weekly 135-min sessions. It draws on social cognitive theory, the reasoned action approach, and focus groups, a prospective survey, and an intervention pilot test with African American men. It contains culturally appropriate video clips, interactive activities, brainstorming, role-playing, and discussions designed to affect hypothesized mediators of risk-reducing behavior, including outcome expectancies about the effects of condom use on sexual enjoyment; self-efficacy and skill to have condoms available and to stop to use condoms or refuse unsafe sex even when aroused; and self-efficacy and skill to negotiate condom use.
|
No-Intervention No-Text Message Control
n=89 Participants
Participants do not receive the STAND HIV Risk Reduction Intervention or the Text Messaging Intervention.
|
HIV Risk Reduction and Text Messaging
n=89 Participants
STAND HIV Risk Reduction Intervention and Text Messaging Intervention. Participants will receive the intervention and text messages.
STAND HIV Risk Reduction Intervention: STAND HIV Risk Reduction Intervention, designed to increase consistent condom use and reduce other sexual risk behaviors, is implemented in small groups over 2 weekly 135-min sessions. It draws on social cognitive theory, the reasoned action approach, and focus groups, a prospective survey, and an intervention pilot test with African American men. It contains culturally appropriate video clips, interactive activities, brainstorming, role-playing, and discussions designed to affect hypothesized mediators of risk-reducing behavior, including outcome expectancies about the effects of condom use on sexual enjoyment; self-efficacy and skill to have condoms available and to stop to use condoms or refuse unsafe sex even when aroused; and self-efficacy and skill to negotiate condom use.
Text Messaging Intervention:
|
Text Messaging Only
n=87 Participants
Text Messaging Intervention. Participants will receive the text messages but not the STAND HIV Risk Reduction Intervention.
Text Messaging Intervention: Text Messaging Intervention participants receive text messages designed to increase the consistent use of condoms and to reduce other sexual risk behaviors. They receive 3 times a week text messages that ask about their sexual behavior and condom use that day and are asked to respond with either a 1 or 2 numeric response to indicate yes or no. Based on their responses, they receive either an affirming, pro safe-sex text message or a cautionary text against unprotected sex.
|
|---|---|---|---|---|
|
Unprotected Intercourse
Baseline steady partners
|
42 Participants
|
31 Participants
|
48 Participants
|
47 Participants
|
|
Unprotected Intercourse
6 mo steady partners
|
46 Participants
|
39 Participants
|
45 Participants
|
46 Participants
|
|
Unprotected Intercourse
12 mo steady partners
|
38 Participants
|
42 Participants
|
43 Participants
|
35 Participants
|
|
Unprotected Intercourse
Baseline casual partners
|
31 Participants
|
41 Participants
|
37 Participants
|
37 Participants
|
|
Unprotected Intercourse
6 mo casual partners
|
23 Participants
|
26 Participants
|
28 Participants
|
22 Participants
|
|
Unprotected Intercourse
12 mo casual partners
|
22 Participants
|
17 Participants
|
25 Participants
|
21 Participants
|
SECONDARY outcome
Timeframe: Baseline, 6 months, 12 months post-interventionPopulation: Participants who provide data on the outcome measure at baseline and at least one post-intervention assessment.
Participants whose number of intercourse partners in the past 90 days was 2 or greater are coded as having multiple partners, and those who reported having 0 or 1 intercourse partners in the past 90 days are coded as not having multiple partners.
Outcome measures
| Measure |
HIV Risk Reduction Only
n=92 Participants
STAND HIV Risk Reduction Intervention. Participants will not receive the Text Messaging Intervention.
STAND HIV Risk Reduction Intervention: STAND HIV Risk Reduction Intervention, designed to increase consistent condom use and reduce other sexual risk behaviors, is implemented in small groups over 2 weekly 135-min sessions. It draws on social cognitive theory, the reasoned action approach, and focus groups, a prospective survey, and an intervention pilot test with African American men. It contains culturally appropriate video clips, interactive activities, brainstorming, role-playing, and discussions designed to affect hypothesized mediators of risk-reducing behavior, including outcome expectancies about the effects of condom use on sexual enjoyment; self-efficacy and skill to have condoms available and to stop to use condoms or refuse unsafe sex even when aroused; and self-efficacy and skill to negotiate condom use.
|
No-Intervention No-Text Message Control
n=89 Participants
Participants do not receive the STAND HIV Risk Reduction Intervention or the Text Messaging Intervention.
|
HIV Risk Reduction and Text Messaging
n=89 Participants
STAND HIV Risk Reduction Intervention and Text Messaging Intervention. Participants will receive the intervention and text messages.
STAND HIV Risk Reduction Intervention: STAND HIV Risk Reduction Intervention, designed to increase consistent condom use and reduce other sexual risk behaviors, is implemented in small groups over 2 weekly 135-min sessions. It draws on social cognitive theory, the reasoned action approach, and focus groups, a prospective survey, and an intervention pilot test with African American men. It contains culturally appropriate video clips, interactive activities, brainstorming, role-playing, and discussions designed to affect hypothesized mediators of risk-reducing behavior, including outcome expectancies about the effects of condom use on sexual enjoyment; self-efficacy and skill to have condoms available and to stop to use condoms or refuse unsafe sex even when aroused; and self-efficacy and skill to negotiate condom use.
Text Messaging Intervention:
|
Text Messaging Only
n=87 Participants
Text Messaging Intervention. Participants will receive the text messages but not the STAND HIV Risk Reduction Intervention.
Text Messaging Intervention: Text Messaging Intervention participants receive text messages designed to increase the consistent use of condoms and to reduce other sexual risk behaviors. They receive 3 times a week text messages that ask about their sexual behavior and condom use that day and are asked to respond with either a 1 or 2 numeric response to indicate yes or no. Based on their responses, they receive either an affirming, pro safe-sex text message or a cautionary text against unprotected sex.
|
|---|---|---|---|---|
|
Multiple Partners
Baseline
|
61 Participants
|
52 Participants
|
59 Participants
|
61 Participants
|
|
Multiple Partners
6 mo
|
40 Participants
|
39 Participants
|
43 Participants
|
45 Participants
|
|
Multiple Partners
12 mo
|
40 Participants
|
33 Participants
|
46 Participants
|
36 Participants
|
SECONDARY outcome
Timeframe: Baseline, 6 months, 12 months post-interventionPopulation: Participants who provided data on the outcome measure at baseline and at least one post-intervention assessment.
A binary variable indicating whether the participant reported having insertive anal intercourse in the past 90 days. Measured separately for steady partners and casual partners and analyzed as a repeated outcome.
Outcome measures
| Measure |
HIV Risk Reduction Only
n=92 Participants
STAND HIV Risk Reduction Intervention. Participants will not receive the Text Messaging Intervention.
STAND HIV Risk Reduction Intervention: STAND HIV Risk Reduction Intervention, designed to increase consistent condom use and reduce other sexual risk behaviors, is implemented in small groups over 2 weekly 135-min sessions. It draws on social cognitive theory, the reasoned action approach, and focus groups, a prospective survey, and an intervention pilot test with African American men. It contains culturally appropriate video clips, interactive activities, brainstorming, role-playing, and discussions designed to affect hypothesized mediators of risk-reducing behavior, including outcome expectancies about the effects of condom use on sexual enjoyment; self-efficacy and skill to have condoms available and to stop to use condoms or refuse unsafe sex even when aroused; and self-efficacy and skill to negotiate condom use.
|
No-Intervention No-Text Message Control
n=90 Participants
Participants do not receive the STAND HIV Risk Reduction Intervention or the Text Messaging Intervention.
|
HIV Risk Reduction and Text Messaging
n=89 Participants
STAND HIV Risk Reduction Intervention and Text Messaging Intervention. Participants will receive the intervention and text messages.
STAND HIV Risk Reduction Intervention: STAND HIV Risk Reduction Intervention, designed to increase consistent condom use and reduce other sexual risk behaviors, is implemented in small groups over 2 weekly 135-min sessions. It draws on social cognitive theory, the reasoned action approach, and focus groups, a prospective survey, and an intervention pilot test with African American men. It contains culturally appropriate video clips, interactive activities, brainstorming, role-playing, and discussions designed to affect hypothesized mediators of risk-reducing behavior, including outcome expectancies about the effects of condom use on sexual enjoyment; self-efficacy and skill to have condoms available and to stop to use condoms or refuse unsafe sex even when aroused; and self-efficacy and skill to negotiate condom use.
Text Messaging Intervention:
|
Text Messaging Only
n=88 Participants
Text Messaging Intervention. Participants will receive the text messages but not the STAND HIV Risk Reduction Intervention.
Text Messaging Intervention: Text Messaging Intervention participants receive text messages designed to increase the consistent use of condoms and to reduce other sexual risk behaviors. They receive 3 times a week text messages that ask about their sexual behavior and condom use that day and are asked to respond with either a 1 or 2 numeric response to indicate yes or no. Based on their responses, they receive either an affirming, pro safe-sex text message or a cautionary text against unprotected sex.
|
|---|---|---|---|---|
|
Insertive Anal Intercourse
Baseline steady partners
|
9 Participants
|
7 Participants
|
11 Participants
|
8 Participants
|
|
Insertive Anal Intercourse
6 mo steady partners
|
10 Participants
|
7 Participants
|
8 Participants
|
10 Participants
|
|
Insertive Anal Intercourse
12 mo steady partners
|
11 Participants
|
12 Participants
|
8 Participants
|
10 Participants
|
|
Insertive Anal Intercourse
Baseline casual partners
|
12 Participants
|
13 Participants
|
11 Participants
|
7 Participants
|
|
Insertive Anal Intercourse
6 mo casual partners
|
7 Participants
|
6 Participants
|
6 Participants
|
4 Participants
|
|
Insertive Anal Intercourse
12 mo casual partners
|
3 Participants
|
5 Participants
|
5 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Baseline, 6 months, 12 months post-interventionPopulation: Participants who provided data on the outcome measure at baseline and at least one post-intervention assessment.
The denominator is the number intercourse acts in the past 90 days and the numerator is the number of condom-protected intercourse acts in the past 90 days. Calculated separately for steady partners and casual partners and analyzed as a repeated outcome.
Outcome measures
| Measure |
HIV Risk Reduction Only
n=67 Participants
STAND HIV Risk Reduction Intervention. Participants will not receive the Text Messaging Intervention.
STAND HIV Risk Reduction Intervention: STAND HIV Risk Reduction Intervention, designed to increase consistent condom use and reduce other sexual risk behaviors, is implemented in small groups over 2 weekly 135-min sessions. It draws on social cognitive theory, the reasoned action approach, and focus groups, a prospective survey, and an intervention pilot test with African American men. It contains culturally appropriate video clips, interactive activities, brainstorming, role-playing, and discussions designed to affect hypothesized mediators of risk-reducing behavior, including outcome expectancies about the effects of condom use on sexual enjoyment; self-efficacy and skill to have condoms available and to stop to use condoms or refuse unsafe sex even when aroused; and self-efficacy and skill to negotiate condom use.
|
No-Intervention No-Text Message Control
n=56 Participants
Participants do not receive the STAND HIV Risk Reduction Intervention or the Text Messaging Intervention.
|
HIV Risk Reduction and Text Messaging
n=74 Participants
STAND HIV Risk Reduction Intervention and Text Messaging Intervention. Participants will receive the intervention and text messages.
STAND HIV Risk Reduction Intervention: STAND HIV Risk Reduction Intervention, designed to increase consistent condom use and reduce other sexual risk behaviors, is implemented in small groups over 2 weekly 135-min sessions. It draws on social cognitive theory, the reasoned action approach, and focus groups, a prospective survey, and an intervention pilot test with African American men. It contains culturally appropriate video clips, interactive activities, brainstorming, role-playing, and discussions designed to affect hypothesized mediators of risk-reducing behavior, including outcome expectancies about the effects of condom use on sexual enjoyment; self-efficacy and skill to have condoms available and to stop to use condoms or refuse unsafe sex even when aroused; and self-efficacy and skill to negotiate condom use.
Text Messaging Intervention:
|
Text Messaging Only
n=71 Participants
Text Messaging Intervention. Participants will receive the text messages but not the STAND HIV Risk Reduction Intervention.
Text Messaging Intervention: Text Messaging Intervention participants receive text messages designed to increase the consistent use of condoms and to reduce other sexual risk behaviors. They receive 3 times a week text messages that ask about their sexual behavior and condom use that day and are asked to respond with either a 1 or 2 numeric response to indicate yes or no. Based on their responses, they receive either an affirming, pro safe-sex text message or a cautionary text against unprotected sex.
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|---|---|---|---|---|
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Proportion Condom-protected Intercourse
Baseline steady partners
|
.51 proportion
Standard Deviation .38
|
.40 proportion
Standard Deviation .42
|
.34 proportion
Standard Deviation .40
|
.42 proportion
Standard Deviation .41
|
|
Proportion Condom-protected Intercourse
6 mo steady partners
|
.39 proportion
Standard Deviation .42
|
.43 proportion
Standard Deviation .40
|
.45 proportion
Standard Deviation .42
|
.45 proportion
Standard Deviation .43
|
|
Proportion Condom-protected Intercourse
12 mo steady partners
|
.46 proportion
Standard Deviation .42
|
.39 proportion
Standard Deviation .40
|
.41 proportion
Standard Deviation .44
|
.44 proportion
Standard Deviation .45
|
|
Proportion Condom-protected Intercourse
Baseline casual partners
|
.71 proportion
Standard Deviation .38
|
.60 proportion
Standard Deviation .37
|
.66 proportion
Standard Deviation .41
|
.59 proportion
Standard Deviation .39
|
|
Proportion Condom-protected Intercourse
6 mo casual partners
|
.56 proportion
Standard Deviation .44
|
.58 proportion
Standard Deviation .40
|
.64 proportion
Standard Deviation .42
|
.64 proportion
Standard Deviation .45
|
|
Proportion Condom-protected Intercourse
12 mo casual partners
|
.69 proportion
Standard Deviation .37
|
.64 proportion
Standard Deviation .42
|
.64 proportion
Standard Deviation .40
|
.58 proportion
Standard Deviation .43
|
Adverse Events
HIV Risk Reduction Only
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
No-Intervention No-Text Message Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
HIV Risk Reduction and Text Messaging
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Text Messaging Only
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place