Trial Outcomes & Findings for HIV Prevention Toolkit for HIV-negative Male Couples (NCT NCT02494817)

NCT ID: NCT02494817

Last Updated: 2019-04-16

Results Overview

Self-reports of yes/no to forming a sexual agreement via electronic survey

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

298 participants

Primary outcome timeframe

6 month

Results posted on

2019-04-16

Participant Flow

Participant milestones

Participant milestones
Measure
Control Group
Couples assigned to the control group will be directed to the website that only has the following: 1) module about learning about effective HIV prevention strategies, 2) sexual health resource center, and 3) a link to download a corresponding smartphone app that will include the sexual health resource center.
Intervention Group
Couples assigned to the intervention group will first, as individuals, view general video about purpose of study and how to use website functions; timeline activity about their relationship; select top values about their relationship; learn about effective HIV prevention strategies; learn about sexual agreements; select what items they want to have in their agreement; explore a learning module about testing and view the sexual health resource center. As a couple, they will log back into the website to view and compare timelines and relationship values; watch a video about communicating more effectively; negotiate and decide together what items they want to include in their agreement; explore the sexual health resource center and/or any other modules from when they were logged into the website as individuals; download a corresponding smartphone app that will include a copy of their newly created agreement and sexual health resource center.
Overall Study
STARTED
162
136
Overall Study
3 Month Assessment
125
92
Overall Study
6 Month Assessment
115
98
Overall Study
COMPLETED
107
87
Overall Study
NOT COMPLETED
55
49

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

HIV Prevention Toolkit for HIV-negative Male Couples

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Control Group
n=162 Participants
Couples assigned to the control group will be directed to the website that only has the following: 1) module about learning about effective HIV prevention strategies, 2) sexual health resource center, and 3) a link to download a corresponding smartphone app that will include the sexual health resource center.
Intervention Group
n=136 Participants
Couples assigned to the intervention group will first as individuals view general video about purpose of study and how to use website functions; timeline activity about their relationship; select top values about their relationship; learn about effective HIV prevention strategies; learn about sexual agreements; select what items they want to have in their agreement; explore a learning module about testing and view the sexual health resource center. As a couple, they will log back into the website to view and compare timelines and relationship values; watch a video about communicating more effectively; negotiate and decide together what items they want to include in their agreement; explore the sexual health resource center and/or any other modules from when they were logged into the website as individuals; download a corresponding smartphone app that will include a copy of their newly created agreement and sexual health resource center.
Total
n=298 Participants
Total of all reporting groups
Age, Continuous
27.55 years
STANDARD_DEVIATION 7.03 • n=5 Participants
28.13 years
STANDARD_DEVIATION 7.33 • n=7 Participants
27.81 years
STANDARD_DEVIATION 7.03 • n=5 Participants
Sex: Female, Male
Female
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Sex: Female, Male
Male
162 Participants
n=5 Participants
136 Participants
n=7 Participants
298 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
24 Participants
n=5 Participants
24 Participants
n=7 Participants
48 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
138 Participants
n=5 Participants
112 Participants
n=7 Participants
250 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
6 Participants
n=7 Participants
6 Participants
n=5 Participants
Race (NIH/OMB)
Asian
6 Participants
n=5 Participants
3 Participants
n=7 Participants
9 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
3 Participants
n=5 Participants
2 Participants
n=7 Participants
5 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
6 Participants
n=5 Participants
6 Participants
n=7 Participants
12 Participants
n=5 Participants
Race (NIH/OMB)
White
147 Participants
n=5 Participants
119 Participants
n=7 Participants
266 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Region of Enrollment
United States
162 participants
n=5 Participants
136 participants
n=7 Participants
298 participants
n=5 Participants
Sexual orientation
gay
156 Participants
n=5 Participants
133 Participants
n=7 Participants
289 Participants
n=5 Participants
Sexual orientation
bisexual
6 Participants
n=5 Participants
3 Participants
n=7 Participants
9 Participants
n=5 Participants
Region of residence
Northeast
19 Participants
n=5 Participants
11 Participants
n=7 Participants
30 Participants
n=5 Participants
Region of residence
Midwest
35 Participants
n=5 Participants
48 Participants
n=7 Participants
83 Participants
n=5 Participants
Region of residence
South
67 Participants
n=5 Participants
39 Participants
n=7 Participants
106 Participants
n=5 Participants
Region of residence
West
39 Participants
n=5 Participants
36 Participants
n=7 Participants
75 Participants
n=5 Participants
Region of residence
US territory
2 Participants
n=5 Participants
2 Participants
n=7 Participants
4 Participants
n=5 Participants
Education
Some High School
7 Participants
n=5 Participants
3 Participants
n=7 Participants
10 Participants
n=5 Participants
Education
High School graduate / GED
20 Participants
n=5 Participants
22 Participants
n=7 Participants
42 Participants
n=5 Participants
Education
Some college / AA / trade
61 Participants
n=5 Participants
56 Participants
n=7 Participants
117 Participants
n=5 Participants
Education
Bachelors degree
45 Participants
n=5 Participants
29 Participants
n=7 Participants
74 Participants
n=5 Participants
Education
Some grad school
13 Participants
n=5 Participants
7 Participants
n=7 Participants
20 Participants
n=5 Participants
Education
Graduate degree
14 Participants
n=5 Participants
19 Participants
n=7 Participants
33 Participants
n=5 Participants
Education
missing data
2 Participants
n=5 Participants
0 Participants
n=7 Participants
2 Participants
n=5 Participants
Employment
Full time
106 Participants
n=5 Participants
90 Participants
n=7 Participants
196 Participants
n=5 Participants
Employment
Part time
18 Participants
n=5 Participants
16 Participants
n=7 Participants
34 Participants
n=5 Participants
Employment
Unemployed
8 Participants
n=5 Participants
7 Participants
n=7 Participants
15 Participants
n=5 Participants
Employment
On disability
8 Participants
n=5 Participants
4 Participants
n=7 Participants
12 Participants
n=5 Participants
Employment
Retired
1 Participants
n=5 Participants
0 Participants
n=7 Participants
1 Participants
n=5 Participants
Employment
Student
21 Participants
n=5 Participants
19 Participants
n=7 Participants
40 Participants
n=5 Participants
Length of current relationship
3-6 months
7 Participants
n=5 Participants
8 Participants
n=7 Participants
15 Participants
n=5 Participants
Length of current relationship
6-12 months
40 Participants
n=5 Participants
25 Participants
n=7 Participants
65 Participants
n=5 Participants
Length of current relationship
1-3 years
69 Participants
n=5 Participants
42 Participants
n=7 Participants
111 Participants
n=5 Participants
Length of current relationship
3-6 years
34 Participants
n=5 Participants
37 Participants
n=7 Participants
71 Participants
n=5 Participants
Length of current relationship
6-10 years
8 Participants
n=5 Participants
16 Participants
n=7 Participants
24 Participants
n=5 Participants
Length of current relationship
10 + years
4 Participants
n=5 Participants
8 Participants
n=7 Participants
12 Participants
n=5 Participants
Relationship status
Domestic partnership
42 Participants
n=5 Participants
28 Participants
n=7 Participants
70 Participants
n=5 Participants
Relationship status
Married
24 Participants
n=5 Participants
40 Participants
n=7 Participants
64 Participants
n=5 Participants
Relationship status
Engaged
27 Participants
n=5 Participants
28 Participants
n=7 Participants
55 Participants
n=5 Participants
Relationship status
None of the above
62 Participants
n=5 Participants
31 Participants
n=7 Participants
93 Participants
n=5 Participants
Relationship status
Other
7 Participants
n=5 Participants
9 Participants
n=7 Participants
16 Participants
n=5 Participants
Relationship type
Monogamous
153 Participants
n=5 Participants
117 Participants
n=7 Participants
270 Participants
n=5 Participants
Relationship type
Open
5 Participants
n=5 Participants
14 Participants
n=7 Participants
19 Participants
n=5 Participants
Relationship type
No label and other
3 Participants
n=5 Participants
5 Participants
n=7 Participants
8 Participants
n=5 Participants
Relationship type
missing data
1 Participants
n=5 Participants
0 Participants
n=7 Participants
1 Participants
n=5 Participants
Had sex with casual male partner (outside relationship)
Yes within last 3 months
29 Participants
n=5 Participants
38 Participants
n=7 Participants
67 Participants
n=5 Participants
Had sex with casual male partner (outside relationship)
No, not within last 3 months
133 Participants
n=5 Participants
98 Participants
n=7 Participants
231 Participants
n=5 Participants
HIV testing frequency (before relationship)
Every 3-4 months
24 Participants
n=5 Participants
15 Participants
n=7 Participants
39 Participants
n=5 Participants
HIV testing frequency (before relationship)
Every 6 months
33 Participants
n=5 Participants
28 Participants
n=7 Participants
61 Participants
n=5 Participants
HIV testing frequency (before relationship)
Once a year
29 Participants
n=5 Participants
30 Participants
n=7 Participants
59 Participants
n=5 Participants
HIV testing frequency (before relationship)
When I felt at risk for HIV
19 Participants
n=5 Participants
18 Participants
n=7 Participants
37 Participants
n=5 Participants
HIV testing frequency (before relationship)
When I dated someone new
6 Participants
n=5 Participants
4 Participants
n=7 Participants
10 Participants
n=5 Participants
HIV testing frequency (before relationship)
No testing pattern
23 Participants
n=5 Participants
21 Participants
n=7 Participants
44 Participants
n=5 Participants
HIV testing frequency (before relationship)
Missing data
28 Participants
n=5 Participants
20 Participants
n=7 Participants
48 Participants
n=5 Participants
HIV testing frequency (since in relationship)
Every 3-4 months
8 Participants
n=5 Participants
0 Participants
n=7 Participants
8 Participants
n=5 Participants
HIV testing frequency (since in relationship)
Every 6 months
14 Participants
n=5 Participants
11 Participants
n=7 Participants
25 Participants
n=5 Participants
HIV testing frequency (since in relationship)
Once a year
26 Participants
n=5 Participants
23 Participants
n=7 Participants
49 Participants
n=5 Participants
HIV testing frequency (since in relationship)
When I felt at risk for HIV
16 Participants
n=5 Participants
20 Participants
n=7 Participants
36 Participants
n=5 Participants
HIV testing frequency (since in relationship)
No testing pattern
38 Participants
n=5 Participants
41 Participants
n=7 Participants
79 Participants
n=5 Participants
HIV testing frequency (since in relationship)
Missing data
60 Participants
n=5 Participants
41 Participants
n=7 Participants
101 Participants
n=5 Participants
When started having anal sex in relationship
5.24 weeks
STANDARD_DEVIATION 10.25 • n=5 Participants
5.96 weeks
STANDARD_DEVIATION 9.59 • n=7 Participants
5.57 weeks
STANDARD_DEVIATION 9.95 • n=5 Participants
When started having condomless anal sex in relationship
10.98 weeks
STANDARD_DEVIATION 20.09 • n=5 Participants
22.91 weeks
STANDARD_DEVIATION 44.38 • n=7 Participants
16.42 weeks
STANDARD_DEVIATION 31.18 • n=5 Participants

PRIMARY outcome

Timeframe: 6 month

Population: For control, 115 men (52 dyads both partners provided data and 11 "dyads" where only one partner provided data) provided outcome data. For intervention, 98 men (45 dyads where both partners provided data and 8 "dyads" where only one partner provided data) provided outcome data. Only dyads where both partners provided data were included.

Self-reports of yes/no to forming a sexual agreement via electronic survey

Outcome measures

Outcome measures
Measure
Control Group
n=104 Participants
Couples assigned to the control group will be directed to the website that only has the following: 1) module about learning about effective HIV prevention strategies, 2) sexual health resource center, and 3) a link to download a corresponding smartphone app that will include the sexual health resource center.
Intervention Group
n=90 Participants
Couples assigned to the intervention group will first as individuals view general video about purpose of study and how to use website functions; timeline activity about their relationship; select top values about their relationship; learn about effective HIV prevention strategies; learn about sexual agreements; select what items they want to have in their agreement; explore a learning module about testing and view the sexual health resource center. As a couple, they will log back into the website to view and compare timelines and relationship values; watch a video about communicating more effectively; negotiate and decide together what items they want to include in their agreement; explore the sexual health resource center and/or any other modules from when they were logged into the website as individuals; download a corresponding smartphone app that will include a copy of their newly created agreement and sexual health resource center.
Formation of a Sexual Agreement at 6 Months
Formed an agreement
56 Participants
66 Participants
Formation of a Sexual Agreement at 6 Months
Did not form an agreement
48 Participants
24 Participants

PRIMARY outcome

Timeframe: 6 month

Population: Participants who provided data in outcome 1 as having a concordant agreement were analyzed.

Self-report of yes/no of adhering to a sexual agreement

Outcome measures

Outcome measures
Measure
Control Group
n=56 Participants
Couples assigned to the control group will be directed to the website that only has the following: 1) module about learning about effective HIV prevention strategies, 2) sexual health resource center, and 3) a link to download a corresponding smartphone app that will include the sexual health resource center.
Intervention Group
n=66 Participants
Couples assigned to the intervention group will first as individuals view general video about purpose of study and how to use website functions; timeline activity about their relationship; select top values about their relationship; learn about effective HIV prevention strategies; learn about sexual agreements; select what items they want to have in their agreement; explore a learning module about testing and view the sexual health resource center. As a couple, they will log back into the website to view and compare timelines and relationship values; watch a video about communicating more effectively; negotiate and decide together what items they want to include in their agreement; explore the sexual health resource center and/or any other modules from when they were logged into the website as individuals; download a corresponding smartphone app that will include a copy of their newly created agreement and sexual health resource center.
Adherence to a Sexual Agreement at 6 Months
Adhered to the agreement
48 Participants
60 Participants
Adherence to a Sexual Agreement at 6 Months
Did not adhere to the agreement
8 Participants
6 Participants

SECONDARY outcome

Timeframe: 3 month

Population: 206 partnered men represent 44 dyads in the intervention arm and 59 dyads in the control arm, respectively. Couple-level findings are reported at the individual level.

Self-reports of yes/no to forming a sexual agreement via electronic survey

Outcome measures

Outcome measures
Measure
Control Group
n=118 Participants
Couples assigned to the control group will be directed to the website that only has the following: 1) module about learning about effective HIV prevention strategies, 2) sexual health resource center, and 3) a link to download a corresponding smartphone app that will include the sexual health resource center.
Intervention Group
n=88 Participants
Couples assigned to the intervention group will first as individuals view general video about purpose of study and how to use website functions; timeline activity about their relationship; select top values about their relationship; learn about effective HIV prevention strategies; learn about sexual agreements; select what items they want to have in their agreement; explore a learning module about testing and view the sexual health resource center. As a couple, they will log back into the website to view and compare timelines and relationship values; watch a video about communicating more effectively; negotiate and decide together what items they want to include in their agreement; explore the sexual health resource center and/or any other modules from when they were logged into the website as individuals; download a corresponding smartphone app that will include a copy of their newly created agreement and sexual health resource center.
Formation of a Sexual Agreement at 3 Months
Formed an agreement
70 Participants
58 Participants
Formation of a Sexual Agreement at 3 Months
Did not form an agreement
48 Participants
30 Participants

SECONDARY outcome

Timeframe: 3 month

Population: Participants who provided data in outcome 3 as having a concordant agreement were analyzed.

Self-reports of yes/no to adhering to a sexual agreement via electronic survey

Outcome measures

Outcome measures
Measure
Control Group
n=70 Participants
Couples assigned to the control group will be directed to the website that only has the following: 1) module about learning about effective HIV prevention strategies, 2) sexual health resource center, and 3) a link to download a corresponding smartphone app that will include the sexual health resource center.
Intervention Group
n=58 Participants
Couples assigned to the intervention group will first as individuals view general video about purpose of study and how to use website functions; timeline activity about their relationship; select top values about their relationship; learn about effective HIV prevention strategies; learn about sexual agreements; select what items they want to have in their agreement; explore a learning module about testing and view the sexual health resource center. As a couple, they will log back into the website to view and compare timelines and relationship values; watch a video about communicating more effectively; negotiate and decide together what items they want to include in their agreement; explore the sexual health resource center and/or any other modules from when they were logged into the website as individuals; download a corresponding smartphone app that will include a copy of their newly created agreement and sexual health resource center.
Adherence to a Sexual Agreement
Adhered to the agreement
62 Participants
54 Participants
Adherence to a Sexual Agreement
Did not adhere to the agreement
8 Participants
4 Participants

SECONDARY outcome

Timeframe: 3 month

Population: 9 of 125 participants in control did not provide data, and 9 of 92 participants in intervention did not provide data.

Self-reports of yes/no of any anal sex with casual male sex partner between months and month 3 via electronic survey

Outcome measures

Outcome measures
Measure
Control Group
n=116 Participants
Couples assigned to the control group will be directed to the website that only has the following: 1) module about learning about effective HIV prevention strategies, 2) sexual health resource center, and 3) a link to download a corresponding smartphone app that will include the sexual health resource center.
Intervention Group
n=83 Participants
Couples assigned to the intervention group will first as individuals view general video about purpose of study and how to use website functions; timeline activity about their relationship; select top values about their relationship; learn about effective HIV prevention strategies; learn about sexual agreements; select what items they want to have in their agreement; explore a learning module about testing and view the sexual health resource center. As a couple, they will log back into the website to view and compare timelines and relationship values; watch a video about communicating more effectively; negotiate and decide together what items they want to include in their agreement; explore the sexual health resource center and/or any other modules from when they were logged into the website as individuals; download a corresponding smartphone app that will include a copy of their newly created agreement and sexual health resource center.
Had Condomless Anal Sex With Casual Male Sex Partner During Months 0-3
Had CAS
7 Participants
5 Participants
Had Condomless Anal Sex With Casual Male Sex Partner During Months 0-3
Did not have CAS
109 Participants
78 Participants

SECONDARY outcome

Timeframe: month 6

Population: Of control participants, only 104 of 115 provided data for this outcome. Of intervention participants, only 90 of 98 provided data for this outcome.

Self-reports of yes/no any anal sex with casual male sex partner, measured at month 6 via electronic survey (about the previous 3 months, i.e., timeframe between months 3-6).

Outcome measures

Outcome measures
Measure
Control Group
n=104 Participants
Couples assigned to the control group will be directed to the website that only has the following: 1) module about learning about effective HIV prevention strategies, 2) sexual health resource center, and 3) a link to download a corresponding smartphone app that will include the sexual health resource center.
Intervention Group
n=90 Participants
Couples assigned to the intervention group will first as individuals view general video about purpose of study and how to use website functions; timeline activity about their relationship; select top values about their relationship; learn about effective HIV prevention strategies; learn about sexual agreements; select what items they want to have in their agreement; explore a learning module about testing and view the sexual health resource center. As a couple, they will log back into the website to view and compare timelines and relationship values; watch a video about communicating more effectively; negotiate and decide together what items they want to include in their agreement; explore the sexual health resource center and/or any other modules from when they were logged into the website as individuals; download a corresponding smartphone app that will include a copy of their newly created agreement and sexual health resource center.
Had Condomless Anal Sex With Casual Male Sex Partner Reported at Month 6
Had CAS
5 Participants
4 Participants
Had Condomless Anal Sex With Casual Male Sex Partner Reported at Month 6
Did not have CAS
99 Participants
86 Participants

SECONDARY outcome

Timeframe: 3 month

Self-reports of yes/no via electronic survey taken at 3 month.

Outcome measures

Outcome measures
Measure
Control Group
n=125 Participants
Couples assigned to the control group will be directed to the website that only has the following: 1) module about learning about effective HIV prevention strategies, 2) sexual health resource center, and 3) a link to download a corresponding smartphone app that will include the sexual health resource center.
Intervention Group
n=92 Participants
Couples assigned to the intervention group will first as individuals view general video about purpose of study and how to use website functions; timeline activity about their relationship; select top values about their relationship; learn about effective HIV prevention strategies; learn about sexual agreements; select what items they want to have in their agreement; explore a learning module about testing and view the sexual health resource center. As a couple, they will log back into the website to view and compare timelines and relationship values; watch a video about communicating more effectively; negotiate and decide together what items they want to include in their agreement; explore the sexual health resource center and/or any other modules from when they were logged into the website as individuals; download a corresponding smartphone app that will include a copy of their newly created agreement and sexual health resource center.
Test for HIV During Past 3 Months (Months 0-3)
Yes, within last 3 months
27 Participants
15 Participants
Test for HIV During Past 3 Months (Months 0-3)
No, not within last 3 months
98 Participants
77 Participants

SECONDARY outcome

Timeframe: month 6

Population: 213 partnered men who completed 6-month assessment

Self-reports of yes/no any test for HIV at month 6 assessment, collected via electronic survey for timeframe between months 3 and 6.

Outcome measures

Outcome measures
Measure
Control Group
n=115 Participants
Couples assigned to the control group will be directed to the website that only has the following: 1) module about learning about effective HIV prevention strategies, 2) sexual health resource center, and 3) a link to download a corresponding smartphone app that will include the sexual health resource center.
Intervention Group
n=98 Participants
Couples assigned to the intervention group will first as individuals view general video about purpose of study and how to use website functions; timeline activity about their relationship; select top values about their relationship; learn about effective HIV prevention strategies; learn about sexual agreements; select what items they want to have in their agreement; explore a learning module about testing and view the sexual health resource center. As a couple, they will log back into the website to view and compare timelines and relationship values; watch a video about communicating more effectively; negotiate and decide together what items they want to include in their agreement; explore the sexual health resource center and/or any other modules from when they were logged into the website as individuals; download a corresponding smartphone app that will include a copy of their newly created agreement and sexual health resource center.
Test for HIV During the Last 3 Months (Months 3-6)
Yes, within last 3 months
27 Participants
11 Participants
Test for HIV During the Last 3 Months (Months 3-6)
No, not within last 3 months
88 Participants
87 Participants

Adverse Events

Control Group

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Intervention Group

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jason W. Mitchell, PhD, MPH

University of Hawaii

Phone: 8082196729

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place