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

Sponsor

University of Colorado, Denver (Other)

Overall Status

Completed

CT.gov ID

NCT00601237

Collaborator

National Institute of Mental Health (NIMH) (NIH)

103

Enrollment

Location

Arms

Duration (Months)

1.9

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections	Behavioral: HIV-related text messaging Behavioral: Nutrition-related text messaging	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

103 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Oct 1, 2008

Actual Primary Completion Date :

May 1, 2013

Actual Study Completion Date :

May 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: A Participants will receive HIV-related text messages	Behavioral: HIV-related text messaging Participants will receive up to 90 text messages related to abstinence, monogamy, and condom use over 3 months.
Active Comparator: B Participants will receive nutrition-related text messages	Behavioral: Nutrition-related text messaging Participants will receive up to 30 text messages about nutrition and healthy eating over 3 months.
No Intervention: C Participants will attend a 90-minute focus group to develop messages for the cell-phone program

Arm

Intervention/Treatment

Experimental: A

Participants will receive HIV-related text messages

Behavioral: HIV-related text messaging

Participants will receive up to 90 text messages related to abstinence, monogamy, and condom use over 3 months.

Active Comparator: B

Participants will receive nutrition-related text messages

Behavioral: Nutrition-related text messaging

Participants will receive up to 30 text messages about nutrition and healthy eating over 3 months.

No Intervention: C

Participants will attend a 90-minute focus group to develop messages for the cell-phone program

Outcome Measures

Primary Outcome Measures

Condom use [Measured at baseline and Months 3 and 6]
Abstinence [Measured at baseline and Months 3 and 6]
Monogamy [Measured at baseline and Months 3 and 6]

Secondary Outcome Measures

Attitudes, norms, self-efficacy, and intentions to remain abstinent, remain monogamous, or use condoms [Measured at baseline and Months 3 and 6]

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years to 20 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Resident of Philadelphia
Self-identified black or African American
English-speaking
Cell phone user

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Motivational Educational Entertainment (MEE) Productions	Philadelphia	Pennsylvania	United States	19107

Sponsors and Collaborators

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

Investigators

Principal Investigator: Sheana Bull, PhD, University of Colorado at Denver and Health Sciences

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Colorado, Denver

ClinicalTrials.gov Identifier:

NCT00601237

Other Study ID Numbers:

07-0463
R21MH083318
COMIRB 07-0463
DAHBR 9A-ASPA

First Posted:

Jan 28, 2008

Last Update Posted:

Apr 3, 2015

Last Verified:

Apr 1, 2015

Keywords provided by University of Colorado, Denver

HIV Prevention

Mobile Phone

Technology-Based Intervention

HIV

HIV Seronegativity

Additional relevant MeSH terms:

HIV Infections

Study Results

No Results Posted as of Apr 3, 2015