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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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
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 group | Role | What they receive |
|---|---|---|
| A | Experimental | Participants will receive HIV-related text messages Receives: Behavioral: HIV-related text messaging |
| B | Active comparator | Participants will receive nutrition-related text messages Receives: Behavioral: Nutrition-related text messaging |
| C | No intervention | Participants 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.
Condom use
Measured: Measured at baseline and Months 3 and 6
Abstinence
Measured: Measured at baseline and Months 3 and 6
Monogamy
Measured: Measured at baseline and Months 3 and 6
Secondary outcomes (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.
- First posted28 Jan 2008 (estimated)
- Study startOct 2008
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Sheana Bull, PhD, Principal investigator, University of Colorado at Denver and Health Sciences
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