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Evaluation of 3T, a Sex-Positive HIV/STI Mobile App Intervention for Young Black Men Ages 14-19 Attracted to Men

Primary Purpose

HIV/AIDS and Infections, Sexual Behavior, Health Knowledge, Attitudes, Practice

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
3T Tune in! Turn on! Turn up!
General Health App
Sponsored by
ETR Associates
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV/AIDS and Infections focused on measuring Healthy relationships

Eligibility Criteria

14 Years - 19 Years (Child, Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  1. self-identification of being aged 14-19;
  2. ownership of an iphone or Android smartphone
  3. self-identification of racial identity as black, African American, or biracial; and
  4. self-identifying as gay, bisexual, same gender loving, or sexually attracted to the same gender.
  5. capacity to assent, based on formal assessment
  6. a willingness to participate after complete understanding of the topics of study, as indicated by a completed assent form
  7. resides in the US

Exclusion Criteria:

  • Anyone not meeting inclusion criteria

Sites / Locations

  • ETRRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

3T Tune in! Turn on! Turn up!

General Health App

Arm Description

The intervention is a mobile app delivered sexual health promotion program designed specifically for young black men who have sex with men or who are attracted to men. The mobile app will include more than 30 interactive activities including resource maps, pre-exposure prophylaxis (PrEP) and post-exposure prophylaxis (PEP) content, and communication forums. The app helps participants to become clearer about what they do/don't want to do sexually, to communicate their choices. It also focuses on ways to increase healthy relationships, enhance sexual experience if having sex while reducing HIV/STI risk. The intervention/app is intended to be used regularly (e.g., two times per week) during the 90 day active participation period.

Participants will download a general health mobile app (focused on promoting drinking water). The control mobile app is intended to be used regularly during the 90 day active participation period.

Outcomes

Primary Outcome Measures

Condomless anal intercourse or condomless vaginal intercourse
Number of times engaged in condomless receptive or insertive anal intercourse or condomless vaginal intercourse in the last 3 months
Condomless anal intercourse or condomless vaginal intercourse
Number of times engaged in condomless receptive or insertive anal intercourse or condomless vaginal intercourse in the last 3 months
Condomless anal intercourse or condomless vaginal intercourse
Number of times engaged in condomless receptive or insertive anal intercourse or condomless vaginal intercourse in the last 3 months

Secondary Outcome Measures

Sexual partners, no condom, in the last 3 months
# partners with whom had anal or vaginal sex without using condoms in the last 3 months
Sexual partners, no condom, in the last 3 months
# partners with whom had anal or vaginal sex without using condoms in the last 3 months
Sexual partners, no condom, in the last 3 months
# partners with whom had anal or vaginal sex without using condoms in the last 3 months
Self-reported STI/HIV testing in last three months
Number of times reported having been tested for STI, including HIV in the last 3 months
Self-reported STI/HIV testing in last three months
Number of times reported having been tested for STI, including HIV in the last 3 months
Self-reported STI/HIV testing in last three months
Number of times reported having been tested for STI, including HIV in the last 3 months
Dyadic Communication Scale
Scale measures beliefs regarding communication with partner about sexual desires/behavior. Average of 6 items on a 5-point scale (1 to 5), with a range of 6 - 30, with a higher score indicating better outcomes
Dyadic Communication Scale
Scale measures beliefs regarding communication with partner about sexual desires/behavior. Average of 6 items on a 5-point scale (1 to 5), with a range of 6 - 30, with a higher score indicating better outcomes
Dyadic Communication Scale
Scale measures beliefs regarding communication with partner about sexual desires/behavior. Average of 6 items on a 5-point scale (1 to 5), with a range of 6 - 30, with a higher score indicating better outcomes
Condom Pleasure Scale
Scale measures beliefs regarding condoms regarding condoms and pleasure. Average of 5 items on a 5-point scale (1 to 5), with a range of 5 - 25, with a higher score indicating better outcomes
Condom Pleasure Scale
Scale measures beliefs regarding condoms regarding condoms and pleasure. Average of 5 items on a 5-point scale (1 to 5), with a range of 5 - 25, with a higher score indicating better outcomes
Condom Pleasure Scale
Scale measures beliefs regarding condoms regarding condoms and pleasure. Average of 5 items on a 5-point scale (1 to 5), with a range of 5 - 25, with a higher score indicating better outcomes
Condom Turn Off Scale
Scale measures beliefs regarding condoms regarding condoms and challenges using them. Average of 5 items on a 5-point scale (1 to 5), with a range of 5 - 25, with a higher score indicating better outcomes
Condom Turn Off Scale
Scale measures beliefs regarding condoms regarding condoms and challenges using them. Average of 5 items on a 5-point scale (1 to 5), with a range of 5 - 25, with a higher score indicating better outcomes
Condom Turn Off Scale
Scale measures beliefs regarding condoms regarding condoms and challenges using them. Average of 5 items on a 5-point scale (1 to 5), with a range of 5 - 25, with a higher score indicating better outcomes

Full Information

First Posted
October 20, 2019
Last Updated
July 26, 2022
Sponsor
ETR Associates
Collaborators
dfusion Inc
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1. Study Identification

Unique Protocol Identification Number
NCT04135443
Brief Title
Evaluation of 3T, a Sex-Positive HIV/STI Mobile App Intervention for Young Black Men Ages 14-19 Attracted to Men
Official Title
Mobile App Promoting Sexual Health for Young Black Men Who Have Sex With Men
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
October 2022 (Anticipated)
Study Completion Date
November 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ETR Associates
Collaborators
dfusion Inc

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study features a 2-arm cluster randomized controlled trial with approximately 300 young black men who have sex with men (YBMSM) to assess the effectiveness of the 3T mobile app. To be eligible participants will be required to identify as male; Black, African-American, or biracial Black/African American; age 14-17 at baseline; self-identify as gay, bisexual, fluid, or sexually attracted to men; own a smartphone, and reside in any state in the United States. Those in the treatment arm will be provided with the 3T app, to be downloaded to their own device, and asked to use it during a three month period. Those in the control arm will be asked to download a general health app and use it during the same three month period. Participants will complete brief online surveys at baseline and at 3- and 6-months following the conclusion of the app-use period to assess effectiveness in changing sexual risk behaviors and communication and condom use behaviors and attitudes.
Detailed Description
The overarching aim of this proposed Phase II research project is to fill a gap in prevention by completing the development and establishing the effectiveness of 3T: Tune in, Turn on, Turn up, a multimedia interactive sex-positive smartphone app-delivered HIV and other sexually transmitted infection (STI) intervention designed for use by YBMSM ages 14-17. The larger and longer term aims of developing an intervention specifically tailored to this population, utilizing a technology platform to reach youth where they are, is to contribute to a reduction in HIV/STI risk, increase HIV testing, and an increase in the quality of overall sexual health and relationships among YBMSM. To do this 3T emphasizes partner reduction, avoidance of concurrent partners, use of condoms if having anal or vaginal sex, and getting HIV/STI tests. 3T also focuses on improving quality of sexual experience and relationships, helping participants become clearer about what they do/don't want to do sexually, communicating their choices, and learning ways to enhance sexual experience without increasing HIV/STI risk. dfusion and its research partner, ETR, will meet the following specific Phase II aims: In conjunction with advisory panel members, develop content and corresponding storyboards for all activities. The curriculum will include content on risk reduction, sexual health and the quality of sexual experiences, and developing healthy relationships; Successful development of the first mobile app-delivered STI/HIV prevention program specifically designed for YBMSM aged 14-17. Reaching this aim requires continued development of the app technology, including the multimedia interactive activities, games, data collection, activity randomization, and a messaging/forum system. Research shows that YBMSM use the Internet to find information related to sex and sexuality, find friends and sexual partners, and YBMSM are increasingly using mobile apps, such as Grindr, to meet sex partners.20 The reliance on mobile devices for education and entertainment make it the ideal technology platform for reaching the YBMSM audience; Conduct a rigorous evaluation to determine the effectiveness of the intervention to reduce HIV/STI risk. The evaluation features a 2-arm cluster randomized controlled trial with approximately 300 young black men who have sex with men (YBMSM) to assess the effectiveness of the 3T mobile app. To be eligible participants will be required to identify as male; Black, African-American, or biracial Black/African American; age 14-17 at baseline; self-identify as gay, bisexual, fluid, or sexually attracted to men; own a smartphone, and reside in any state in the United States. Those in the treatment arm will be provided with the 3T app, to be downloaded to their own device, and asked to use it during a three month period. Those in the control arm will be asked to download a general health app and use it during the same three month period. Participants will complete brief online surveys at baseline and at 3- and 6-months following the conclusion of the app-use period to assess effectiveness in changing sexual risk behaviors and relationship and communication behaviors and attitudes. Recruitment. We will use a chain-referral technique for recruiting, starting with a group of 100 "seeds" recruited using a multi-pronged strategy including: 1) Engaging Organizations. Approximately 15-20 organizations from across the U.S. that serve YBMSM will be approached to help recruit participants through social media and in-person (see letters of support.) 2) Using Google Adwords. Placing study advertisements on Google based on keyword for participant recruitment; 3) Using Social Media Advertising including targeted advertising on social media sites and sponsoring study posts with social media influencers in the YBMSM community. To minimize contamination, we will randomize initial seeds and all persons in their recruitment chain to either the treatment arm or the attention control arm.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV/AIDS and Infections, Sexual Behavior, Health Knowledge, Attitudes, Practice
Keywords
Healthy relationships

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This is a two arm cluster randomized controlled trial. Because the evaluation is using cluster randomization, the participants will be randomized by cluster into an attention control or intervention group. There will be 100 seeds. Each seed will receive 3 referral coupons. Upon completing a baseline survey the seed will be randomized into treatment or control condition. Any participant using a referral coupon will be placed in the same condition as the initial seed with which they are associated. After randomization, participants will be granted access to download and install their assigned mobile app (3T or a general health app).
Masking
None (Open Label)
Masking Description
Participants are randomly assigned to their condition without being made aware of their assigned condition as "attention control" or "intervention." Each condition downloads and uses an app so study activities are similar, reducing the likelihood participants will be aware of their assigned condition.
Allocation
Randomized
Enrollment
250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
3T Tune in! Turn on! Turn up!
Arm Type
Experimental
Arm Description
The intervention is a mobile app delivered sexual health promotion program designed specifically for young black men who have sex with men or who are attracted to men. The mobile app will include more than 30 interactive activities including resource maps, pre-exposure prophylaxis (PrEP) and post-exposure prophylaxis (PEP) content, and communication forums. The app helps participants to become clearer about what they do/don't want to do sexually, to communicate their choices. It also focuses on ways to increase healthy relationships, enhance sexual experience if having sex while reducing HIV/STI risk. The intervention/app is intended to be used regularly (e.g., two times per week) during the 90 day active participation period.
Arm Title
General Health App
Arm Type
Active Comparator
Arm Description
Participants will download a general health mobile app (focused on promoting drinking water). The control mobile app is intended to be used regularly during the 90 day active participation period.
Intervention Type
Behavioral
Intervention Name(s)
3T Tune in! Turn on! Turn up!
Intervention Description
A sex positive multimedia interactive mobile app delivered HIV/STI intervention developed for use by YBMSM ages 14-17. The program employs a theory based approach to address essential knowledge, perceptions of risk, peer norms, attitudes and skill with two primary goals: (1) To reduce HIV/STI the program emphasizes partner reduction, avoidance of concurrent partners, condoms and HIV/STI tests; and (2) To improve sexual health and relationships.
Intervention Type
Behavioral
Intervention Name(s)
General Health App
Intervention Description
The control group will download a mobile app that addresses general health behaviors, specifically drinking more water.
Primary Outcome Measure Information:
Title
Condomless anal intercourse or condomless vaginal intercourse
Description
Number of times engaged in condomless receptive or insertive anal intercourse or condomless vaginal intercourse in the last 3 months
Time Frame
Baseline, before intervention period
Title
Condomless anal intercourse or condomless vaginal intercourse
Description
Number of times engaged in condomless receptive or insertive anal intercourse or condomless vaginal intercourse in the last 3 months
Time Frame
3 months post intervention period
Title
Condomless anal intercourse or condomless vaginal intercourse
Description
Number of times engaged in condomless receptive or insertive anal intercourse or condomless vaginal intercourse in the last 3 months
Time Frame
6 months post intervention period
Secondary Outcome Measure Information:
Title
Sexual partners, no condom, in the last 3 months
Description
# partners with whom had anal or vaginal sex without using condoms in the last 3 months
Time Frame
Baseline, before intervention period
Title
Sexual partners, no condom, in the last 3 months
Description
# partners with whom had anal or vaginal sex without using condoms in the last 3 months
Time Frame
3 months post intervention period
Title
Sexual partners, no condom, in the last 3 months
Description
# partners with whom had anal or vaginal sex without using condoms in the last 3 months
Time Frame
6 months post intervention period
Title
Self-reported STI/HIV testing in last three months
Description
Number of times reported having been tested for STI, including HIV in the last 3 months
Time Frame
Baseline, before intervention period
Title
Self-reported STI/HIV testing in last three months
Description
Number of times reported having been tested for STI, including HIV in the last 3 months
Time Frame
3 months post intervention period
Title
Self-reported STI/HIV testing in last three months
Description
Number of times reported having been tested for STI, including HIV in the last 3 months
Time Frame
6 months post intervention period
Title
Dyadic Communication Scale
Description
Scale measures beliefs regarding communication with partner about sexual desires/behavior. Average of 6 items on a 5-point scale (1 to 5), with a range of 6 - 30, with a higher score indicating better outcomes
Time Frame
Baseline, before intervention period
Title
Dyadic Communication Scale
Description
Scale measures beliefs regarding communication with partner about sexual desires/behavior. Average of 6 items on a 5-point scale (1 to 5), with a range of 6 - 30, with a higher score indicating better outcomes
Time Frame
3 months post intervention period
Title
Dyadic Communication Scale
Description
Scale measures beliefs regarding communication with partner about sexual desires/behavior. Average of 6 items on a 5-point scale (1 to 5), with a range of 6 - 30, with a higher score indicating better outcomes
Time Frame
6 months post intervention period
Title
Condom Pleasure Scale
Description
Scale measures beliefs regarding condoms regarding condoms and pleasure. Average of 5 items on a 5-point scale (1 to 5), with a range of 5 - 25, with a higher score indicating better outcomes
Time Frame
Baseline, before intervention period
Title
Condom Pleasure Scale
Description
Scale measures beliefs regarding condoms regarding condoms and pleasure. Average of 5 items on a 5-point scale (1 to 5), with a range of 5 - 25, with a higher score indicating better outcomes
Time Frame
3 months post intervention period
Title
Condom Pleasure Scale
Description
Scale measures beliefs regarding condoms regarding condoms and pleasure. Average of 5 items on a 5-point scale (1 to 5), with a range of 5 - 25, with a higher score indicating better outcomes
Time Frame
6 months post intervention period
Title
Condom Turn Off Scale
Description
Scale measures beliefs regarding condoms regarding condoms and challenges using them. Average of 5 items on a 5-point scale (1 to 5), with a range of 5 - 25, with a higher score indicating better outcomes
Time Frame
Baseline, before intervention period
Title
Condom Turn Off Scale
Description
Scale measures beliefs regarding condoms regarding condoms and challenges using them. Average of 5 items on a 5-point scale (1 to 5), with a range of 5 - 25, with a higher score indicating better outcomes
Time Frame
3 months post intervention period
Title
Condom Turn Off Scale
Description
Scale measures beliefs regarding condoms regarding condoms and challenges using them. Average of 5 items on a 5-point scale (1 to 5), with a range of 5 - 25, with a higher score indicating better outcomes
Time Frame
6 months post intervention period

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
self-identifying as gay, bisexual, same gender loving, or sexually attracted to the same gender
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: self-identification of being aged 14-19; ownership of an iphone or Android smartphone self-identification of racial identity as black, African American, or biracial; and self-identifying as gay, bisexual, same gender loving, or sexually attracted to the same gender. capacity to assent, based on formal assessment a willingness to participate after complete understanding of the topics of study, as indicated by a completed assent form resides in the US Exclusion Criteria: Anyone not meeting inclusion criteria
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tamara Kuhn, MS
Phone
8314402104
Email
tamara.kuhn@dfusioninc.com
First Name & Middle Initial & Last Name or Official Title & Degree
Karin Coyle, PhD
Phone
8314402140
Email
karin.coyle@etr.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tamara Kuhn, MS
Organizational Affiliation
dfusion Inc
Official's Role
Principal Investigator
Facility Information:
Facility Name
ETR
City
Scotts Valley
State/Province
California
ZIP/Postal Code
95066
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karin Coyle, PhD
Phone
831-440-2140
Email
karin.coyle@etr.org
First Name & Middle Initial & Last Name & Degree
Karin Coyle, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Evaluation of 3T, a Sex-Positive HIV/STI Mobile App Intervention for Young Black Men Ages 14-19 Attracted to Men

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