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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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HIV Infections

Intervention / Treatment
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* Behavioral: HIV-related text messaging
* Behavioral: Nutrition-related text messaging


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Resident of Philadelphia Self-identified black or African American English-speaking Cell phone user

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 20 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Attitudes, norms, self-efficacy, and intentions to remain abstinent, remain monogamous, or use condoms |  | Measured at baseline and Months 3 and 6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV Prevention, Mobile Phone, Technology-Based Intervention, HIV, HIV Seronegativity