Effectiveness of a Cell Phone-Based Program for Abstinence and HIV Risk Prevention

HIV Infections Clinical Trial

Official title:

Text Messaging for Abstinence and HIV Risk Prevention: The 411 on Safe Text

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00601237
• Other study ID #: 07-0463
• Secondary ID: R21MH083318COMIR
• Status: Completed
• Phase: N/A
• First received: January 23, 2008
• Last updated: April 1, 2015
• Start date: October 2008
• Est. completion date: May 2013

Study information

• Verified date: April 2015
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

This study will develop and test the effectiveness of a cell phone-based text messaging program to encourage abstinence, monogamy, or condom use among black urban males in Philadelphia, Pennsylvania.

Description:

Sexually transmitted diseases (STDs), including HIV infections, are most commonly spread through unprotected sexual intercourse. STDs are a primary health issue, especially among young ethnic minorities in the United States. The rate of STDs is significantly greater in urban areas where ethnic minorities, particularly African-American males, are commonly represented. Despite this information, safe sexual practices, including correct condom use, are not commonly followed among minority males. It is believed that educational outreach designed to motivate and inform on the correct use of condoms will be effective in encouraging safer sex practices. A cell phone-based text messaging program designed to promote safer sex practices may provide an effective and easy means of delivery of treatment. This study will develop and test the effectiveness of a cell phone-based text messaging program to sustain abstinence, monogamy, or condom use among black urban males in Philadelphia, Pennsylvania.

Participation in this study will be divided into two phases. In the first study phase, participants will partake in a 90-minute focus group to help develop text message content and plans for treatment delivery. The next study phase will be a pilot test of the program developed in the first phase. Participants will be assigned to receive text messages concerning either HIV prevention or general nutrition. Participants receiving the HIV prevention text messages will be sent up to 90 text messages related to abstinence, monogamy, and condom use over a 3-month period. Participants will also be able to join interactive phone activities related to HIV. Participants receiving the nutritional text messages will be sent up to 30 messages about nutrition and healthy eating over the same period of time. Participants will complete telephone surveys at baseline and Months 3 and 6. The surveys will assess measures of abstinence, monogamy and condom use attitudes, norms, self-efficacy, and risk behaviors.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 16 Years to 20 Years

Eligibility

Inclusion Criteria:

• Resident of Philadelphia

• Self-identified black or African American

• English-speaking

• Cell phone user

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• HIV Infections

Intervention

Behavioral:
• HIV-related text messaging
Participants will receive up to 90 text messages related to abstinence, monogamy, and condom use over 3 months.
• Nutrition-related text messaging
Participants will receive up to 30 text messages about nutrition and healthy eating over 3 months.

Locations

Country	Name	City	State
United States	Motivational Educational Entertainment (MEE) Productions	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Condom use		Measured at baseline and Months 3 and 6	No
Primary	Abstinence		Measured at baseline and Months 3 and 6	No
Primary	Monogamy		Measured at baseline and Months 3 and 6	No
Secondary	Attitudes, norms, self-efficacy, and intentions to remain abstinent, remain monogamous, or use condoms		Measured at baseline and Months 3 and 6	No