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HIV InfectionsNCT00601237

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

A study testing HIV-related text messaging and Nutrition-related text messaging in people with HIV Infections, run by University of Colorado, Denver at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?
Ages 16 to 20 years, men onlyHealthy volunteers can take part
Conditions the study is for
HIV Infections
What is being tested?
HIV-related text messaging and Nutrition-related text messaging
Could I receive a placebo?
No, everyone receives an active treatment
How many people
103 participants
Where
1 siteUnited States
Study dates
Oct 2008to May 2013
Phase
Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 to 20 years
  • Men only
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

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

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Motivational Educational Entertainment (MEE) Productions

    Philadelphia, Pennsylvania, 19107

Other trials in United States

About this study

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

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.

Read the 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.

Conditions
HIV Infections
Being tested
HIV-related text messaging, Nutrition-related text messaging
Keywords
HIV Prevention, Mobile Phone, Technology-Based Intervention, HIV, HIV Seronegativity
Medical subject headings
HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HIV-related text messagingBehavioural

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

  • Nutrition-related text messagingBehavioural

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

Study groups in NCT00601237
Study groupRoleWhat they receive
AExperimentalParticipants will receive HIV-related text messages
Receives: Behavioral: HIV-related text messaging
BActive comparatorParticipants will receive nutrition-related text messages
Receives: Behavioral: Nutrition-related text messaging
CNo interventionParticipants will attend a 90-minute focus group to develop messages for the cell-phone program

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Condom use

    Measured: Measured at baseline and Months 3 and 6

  2. Abstinence

    Measured: Measured at baseline and Months 3 and 6

  3. Monogamy

    Measured: Measured at baseline and Months 3 and 6

Secondary outcomes (1)
  1. Attitudes, norms, self-efficacy, and intentions to remain abstinent, remain monogamous, or use condoms

    Measured: Measured at baseline and Months 3 and 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jan 2008 (estimated)
  2. Study startOct 2008
  3. Primary completionMay 2013
  4. Study completionMay 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
103 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00601237
Sponsor's protocol ID
07-0463
Other IDs
R21MH083318, COMIRB 07-0463, DAHBR 9A-ASPA
Status last verified
Apr 2015
First submitted
23 Jan 2008
Last updated
3 Apr 2015
Results posted
No
Data monitoring committee
No

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