Sexually Transmitted DiseasesNCT01553682
Project N-Liten- HIV Prevention for African American Women
A study testing Horizons+General Health Promotion (GHP) and Horizons+Motivational Enhancement Therapy (GMET) in people with Sexually Transmitted Diseases, run by Emory University at 1 site in United States.
Trial summary
Young African-American women who report a higher frequency of alcohol use have particularly higher rates of sexually transmitted diseases (STDs) and human immunodeficiency virus (HIV) sex behaviors. Read more about this study
- Who is it for?
- Ages 18 to 24 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sexually Transmitted Diseases
- What is being tested?
- Horizons+General Health Promotion (GHP) and Horizons+Motivational Enhancement Therapy (GMET)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 560 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2011to Mar 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 24 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- To be eligible, participants must be:
- African American women;
- 18-24 years of age, inclusive at time of enrollment;
- unmarried;
- report having at least one episode of unprotected vaginal or anal sex in the past 90 days;
- report ≥ 3 alcohol drinking episodes in the past 90 days;
- not pregnant; and
- provide written informed consent.
Who cannot join
- Those with:
- the presence of active psychosis reflected by the participant's status during the baseline assessment, and/or
- an acute or chronic illness that could preclude participation for the duration of the program and follow-up will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reducing Alcohol-Related HIV Risk in African American Females
Young African-American women who report a higher frequency of alcohol use have particularly higher rates of sexually transmitted diseases (STDs) and human immunodeficiency virus (HIV) sex behaviors. Unfortunately, there are no evidence-based HIV interventions designed to be gender- and culturally-appropriate for this population. To address this, the investigators propose to add to the CDC-defined evidence-based intervention (DEBI), Horizons, a new intervention form, Group Motivational Enhancement Therapy (GMET), which has shown promise in reducing alcohol use and alcohol-related HIV risk-taking. To test how effective the combined Horizons+GMET alcohol-specific portion is, it will be evaluated with a time equivalent Horizons+attention control general health promotion (GHP) portion focusing on nutrition health promotion, and to an enhanced standard-of-care program. In this study, 600 young African American women, 18-24 years of age, who report 3 or more occasions where they drank alcohol in the past 90 days will be recruited to complete a four-part baseline assessment consisting of: 1. an audio computer assisted self interview (ACASI), 2. videotaped communication role plays to objectively measure communication skill ability (subsample), 3. provide a vaginal specimen to test for STDs and 4. Provide a urine pregnancy screen. After participants complete their baseline assessment, they will be randomly assigned to one of three conditions: 1. Horizons+GMET alcohol-specific condition, 2. a time-equivalent Horizons+GHP condition, or 3. an enhanced standard-of-care control condition. The GMET alcohol-specific component has shown to be effective in influencing several alcohol-specific concepts (attitudes, norms, self-efficacy) and reducing sexual risk-taking among culturally-diverse high-risk youth. The GMET alcohol-specific module was designed to increase woman's awareness of the unfavorable effects of alcohol on themselves, their sexual decision-making, and their male partner and teaches women strategies to reduce the possibility of engaging in sex under the influence of alcohol. In addition, the GMET alcohol-specific module provides skills training needed to effectively talk about sexual intentions to use condoms and/or refuse risky sex when they or their male sex partner has been using alcohol. After completing one of the three conditions, participants will complete a brief ACASI posttest to evaluate immediate changes in hypothesized social and psychological mediators of safer sex and alcohol use. Participants will also return to complete follow-up assessments at 3, 6, 9, and 12-months after their intervention. If the Horizons+GMET intervention is observed to be effective, investigators will work closely with the CDC DEBI program to help distribute the intervention to public health agencies and community based organizations (CBOs).
- Conditions
- Sexually Transmitted Diseases
- Being tested
- Horizons+General Health Promotion (GHP), Horizons+Motivational Enhancement Therapy (GMET)
- Keywords
- HIV, STDs, African American Females, Alcohol
- Medical subject headings
- Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Horizons+General Health Promotion (GHP)Behavioural
Participants will attend the Horizons HIV Prevention Program with an extra workshop on nutrition health promotion. Participants will attend a total of two (2) 5-hour workshops over 2 consecutive Saturdays. They will be led by African American health educators, and have about 8-12 other young women participants. The workshops will discuss gender and ethnic pride, self-esteem, good role models, and how to reduce risky sexual behavior. The nutrition health promotion workshop will give ideas on healthy nutrition and exercise. Participants will be asked to rate the workshop anonymously.
Horizons+Motivational Enhancement Therapy (GMET)Behavioural
Participants will attend the Horizons Plus HIV Prevention Program. Participants will attend a total of two (2) 5-hour workshops over 2 consecutive Saturdays. They will be led by African American health educators, and have about 8-12 other young women participants. The workshops will discuss gender and ethnic pride, self-esteem, good role models, and how to reduce risky sexual behavior. Participants will be asked to rate the workshop anonymously.
| Study group | Role | What they receive |
|---|---|---|
| Enhanced Standard-Of-Care | No intervention | Participants will watch a video about how to prevent STIs and HIV, then do question and answer session. This group will be last 1 hour. It will be led by one African American health educator, and have about 4-8 other young women participants. Participants will be asked to rate the workshop anonymously. |
| Horizons+General Health Promotion (GHP) | Active comparator | Participants will attend the Horizons HIV Prevention Program with an extra workshop on nutrition health promotion. Participants will attend a total of two (2) 5-hour workshops over 2 consecutive Saturdays. They will be led by African American health educators, and have about 8-12 other young women participants. The workshops will discuss gender and ethnic pride, self-esteem, good role models, and how to reduce risky sexual behavior. The nutrition health promotion workshop will give ideas on healthy nutrition and exercise. Participants will be asked to rate the workshop anonymously. Receives: Behavioral: Horizons+General Health Promotion (GHP) |
| Horizons+Motivational Enhancement Therapy (GMET) | Experimental | Participants will attend the Horizons Plus HIV Prevention Program. Participants will attend a total of two (2) 5-hour workshops over 2 consecutive Saturdays. They will be led by African American health educators, and have about 8-12 other young women participants. The workshops will discuss gender and ethnic pride, self-esteem, good role models, and how to reduce risky sexual behavior. Participants will be asked to rate the workshop anonymously. Receives: Behavioral: Horizons+Motivational Enhancement Therapy (GMET) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incident STD infection confirmed by laboratory PRC testing over a 12-month follow-up.
Incident STD infection confirmed by laboratory PRC testing.
Measured: 12 months post-randomization
Secondary outcomes (1)
Proportion of condom-protected vaginal or anal sex acts over a 12-month follow-up.
Assessed by ACASI
Measured: 12 months post-randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2012 (estimated)
- Study startDec 2011
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sexually Transmitted DiseasesStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe 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
- 560 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ralph J. DiClemente, Emory University
- Investigators
- Ralph J DiClemente, PhD, Principal investigator, Emory UniversityJennifer L. Monahan, PhD, Principal investigator, University of Georgia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01553682
- Sponsor's protocol ID
- IRB00048502
- Other IDs
- 5R01AA018096
- Status last verified
- Jun 2015
- First submitted
- 5 Mar 2012
- Last updated
- 25 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
DiClemente RJ, Rosenbaum JE, Rose ES, Sales JM, Brown JL, Renfro TL, Bradley ELP, Davis TL, Capasso A, Wingood GM, Liu Y, West SG, Hardin JW, Bryan AD, Feldstein Ewing SW. Horizons and Group Motivational Enhancement Therapy: HIV Prevention for Alcohol-Using Young Black Women, a Randomized Experiment. Am J Prev Med. 2021 May;60(5):629-638. doi: 10.1016/j.amepre.2020.11.014. Epub 2021 Mar 5.
PubMed 33678517
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Alcohol-Related HIV Risk in African American Females
- ClinicalTrials.gov ID
- NCT01553682
- Acronym / sponsor ID
- IRB00048502
- Conditions
- Sexually Transmitted Diseases
- Keywords
- HIV, STDs, African American Females, Alcohol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 560 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 14 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Young African-American women who report a higher frequency of alcohol use have particularly higher rates of sexually transmitted diseases (STDs) and human immunodeficiency virus (HIV) sex behaviors. Unfortunately, there are no evidence-based HIV interventions designed to be gender- and culturally-appropriate for this population. To address this, the investigators propose to add to the CDC-defined evidence-based intervention (DEBI), Horizons, a new intervention form, Group Motivational Enhancement Therapy (GMET), which has shown promise in reducing alcohol use and alcohol-related HIV risk-taking. To test how effective the combined Horizons+GMET alcohol-specific portion is, it will be evaluated with a time equivalent Horizons+attention control general health promotion (GHP) portion focusing on nutrition health promotion, and to an enhanced standard-of-care program. In this study, 600 young African American women, 18-24 years of age, who report 3 or more occasions where they drank alcohol in the past 90 days will be recruited to complete a four-part baseline assessment consisting of: 1. an audio computer assisted self interview (ACASI), 2. videotaped communication role plays to objectively measure communication skill ability (subsample), 3. provide a vaginal specimen to test for STDs and 4. Provide a urine pregnancy screen. After participants complete their baseline assessment, they will be randomly assigned to one of three conditions: 1. Horizons+GMET alcohol-specific condition, 2. a time-equivalent Horizons+GHP condition, or 3. an enhanced standard-of-care control condition. The GMET alcohol-specific component has shown to be effective in influencing several alcohol-specific concepts (attitudes, norms, self-efficacy) and reducing sexual risk-taking among culturally-diverse high-risk youth. The GMET alcohol-specific module was designed to increase woman's awareness of the unfavorable effects of alcohol on themselves, their sexual decision-making, and their male partner and teaches women strategies to reduce the possibility of engaging in sex under the influence of alcohol. In addition, the GMET alcohol-specific module provides skills training needed to effectively talk about sexual intentions to use condoms and/or refuse risky sex when they or their male sex partner has been using alcohol. After completing one of the three conditions, participants will complete a brief ACASI posttest to evaluate immediate changes in hypothesized social and psychological mediators of safer sex and alcohol use. Participants will also return to complete follow-up assessments at 3, 6, 9, and 12-months after their intervention. If the Horizons+GMET intervention is observed to be effective, investigators will work closely with the CDC DEBI program to help distribute the intervention to public health agencies and community based organizations (CBOs).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Enhanced Standard-Of-Care | No intervention | –Participants will watch a video about how to prevent STIs and HIV, then do question and answer session. This group will be last 1 hour. It will be led by one African American health educator, and have about 4-8 other young women participants. Participants will be asked to rate the workshop anonymously. |
| Horizons+General Health Promotion (GHP) | Active comparator | Behavioral: Horizons+General Health Promotion (GHP)Participants will attend the Horizons HIV Prevention Program with an extra workshop on nutrition health promotion. Participants will attend a total of two (2) 5-hour workshops over 2 consecutive Saturdays. They will be led by African American health educators, and have about 8-12 other young women participants. The workshops will discuss gender and ethnic pride, self-esteem, good role models, and how to reduce risky sexual behavior. The nutrition health promotion workshop will give ideas on healthy nutrition and exercise. Participants will be asked to rate the workshop anonymously. |
| Horizons+Motivational Enhancement Therapy (GMET) | Experimental | Behavioral: Horizons+Motivational Enhancement Therapy (GMET)Participants will attend the Horizons Plus HIV Prevention Program. Participants will attend a total of two (2) 5-hour workshops over 2 consecutive Saturdays. They will be led by African American health educators, and have about 8-12 other young women participants. The workshops will discuss gender and ethnic pride, self-esteem, good role models, and how to reduce risky sexual behavior. Participants will be asked to rate the workshop anonymously. |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- To be eligible, participants must be:
Key exclusion criteria (3 listed)
- Those with:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Horizons+General Health Promotion (GHP)Participants will attend the Horizons HIV Prevention Program with an extra workshop on nutrition health promotion. Participants will attend a total of two (2) 5-hour workshops over 2 consecutive Saturdays. They will be led by African American health educators, and have about 8-12 other young women participants. The workshops will discuss gender and ethnic pride, self-esteem, good role models, and how to reduce risky sexual behavior. The nutrition health promotion workshop will give ideas on healthy nutrition and exercise. Participants will be asked to rate the workshop anonymously. | Behavioural | Horizons+General Health Promotion (GHP) |
| Horizons+Motivational Enhancement Therapy (GMET)Participants will attend the Horizons Plus HIV Prevention Program. Participants will attend a total of two (2) 5-hour workshops over 2 consecutive Saturdays. They will be led by African American health educators, and have about 8-12 other young women participants. The workshops will discuss gender and ethnic pride, self-esteem, good role models, and how to reduce risky sexual behavior. Participants will be asked to rate the workshop anonymously. | Behavioural | Horizons+Motivational Enhancement Therapy (GMET) |
Primary outcome
Incident STD infection confirmed by laboratory PRC testing over a 12-month follow-up.
Time frame: 12 months post-randomization
Incident STD infection confirmed by laboratory PRC testing.
1 secondary outcome
Proportion of condom-protected vaginal or anal sex acts over a 12-month follow-up.
Time frame: 12 months post-randomization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2015.
- Derived from this study: PubMed 33678517DiClemente RJ, Rosenbaum JE, Rose ES, Sales JM, Brown JL, Renfro TL, Bradley ELP, Davis TL, Capasso A, Wingood GM, Liu Y, West SG, Hardin JW, Bryan AD, Feldstein Ewing SW. Horizons and Group Motivational Enhancement Therapy: HIV Prevention for Alcohol-Using Young Black Women, a Randomized Experiment. Am J Prev Med. 2021 May;60(5):629-638. doi: 10.1016/j.amepre.2020.11.014. Epub 2021 Mar 5.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ralph J DiClemente, PhD principal investigator
Emory University
Jennifer L. Monahan, PhD principal investigator
University of Georgia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Horizons+General Health Promotion (GHP) and Horizons+Motivational Enhancement Therapy (GMET) in people with Sexually Transmitted Diseases, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incident STD infection confirmed by laboratory PRC testing over a 12-month follow-up. (time frame: 12 months post-randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01553682, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2015.