Clinical trial NCT00601237: Effectiveness of a Cell Phone-Based Program for Abstinence and HIV Risk Prevention
Official title: Text Messaging for Abstinence and HIV Risk Prevention: The 411 on Safe Text
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Keywords: HIV Prevention
Mobile Phone
Technology-Based Intervention
HIV
HIV Seronegativity
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2008-01-28
Enrollment: 103
Sex: MALE
Minimum age (years): 16
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: Inclusion Criteria:

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

Primary outcomes:
measure: Condom use
timeFrame: Measured at baseline and Months 3 and 6
measure: Abstinence
timeFrame: Measured at baseline and Months 3 and 6
measure: Monogamy
timeFrame: Measured at baseline and Months 3 and 6
Secondary outcomes:
measure: Attitudes, norms, self-efficacy, and intentions to remain abstinent, remain monogamous, or use condoms
timeFrame: Measured at baseline and Months 3 and 6
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Motivational Educational Entertainment (MEE) Productions
state: Pennsylvania
Study officials:
affiliation: University of Colorado at Denver and Health Sciences
name: Sheana Bull, PhD
role: PRINCIPAL_INVESTIGATOR
References: