HIV InfectionsHORIZONSNCT00633906
HORIZONS HIV Intervention
A study testing HORIZONS HIV Intervention and enhanced standard-of-care in people with HIV Infections and Sexually Transmitted Diseases, run by Emory University at 3 sites in United States.
Trial summary
The Horizons Program will test the efficacy of a multi-session HIV prevention program for African American female teens attending reproductive health clinics in Atlanta, GA. Read more about this study
- Who is it for?
- Ages 15 to 21 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Infections, Sexually Transmitted Diseases
- What is being tested?
- HORIZONS HIV Intervention and enhanced standard-of-care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 715 participants
- Where
- 3 sitesUnited States
- Study dates
- Apr 2002to Oct 2005
- 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 15 to 21 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Female
- African American
- Ages 15-21
- Receiving care at participating clinic
- Vaginal sex in the past 60 days
- Ability to give written informed consent
Who cannot join
- Married
- Pregnant
- In a detention center
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Fulton County Department of Health and Wellness
Atlanta, Georgia, 30303
Grady Teen Clinic
Atlanta, Georgia, 30303
Planned Parenthood of GA
Atlanta, Georgia, 30303
About this study
Official title: Reducing HIV Risk in Female Teens: A Tailored Approach
The Horizons Program will test the efficacy of a multi-session HIV prevention program for African American female teens attending reproductive health clinics in Atlanta, GA.
Read the detailed description
African-American adolescent females are a population at high risk for HIV infection. Recent findings suggest that culturally and gender appropriate HIV interventions can significantly reduce HIV-associated sexual risk behaviors among this vulnerable population. The Horizons HIV intervention was developed for African-American female adolescents attending reproductive health clinics in Atlanta, GA. The specific objectives were:
- To evaluate the efficacy of the HORIZONS HIV intervention plus standard of care counseling versus the standard of care counseling alone in reducing self-reported HIV sexual risk behaviors and incident STDs over a 12 month follow-up period.
- To evaluate the cost-effectiveness of the HORIZONS HIV intervention plus standard of care counseling to the standard of care counseling alone with respect to reducing risky sexual behavior and averting incident STDs.
715 participants, ages 15-21, were recruited and enrolled at a large urban county health department, a teen clinic in a public hospital and a reproductive health clinic in the Atlanta area. After a computer interview assessing adolescents' sexual risk and preventive behaviors, and STD testing (Chlamydia and gonorrhea), participants were randomized to one of 2 conditions: the HORIZONS Intervention or the Standard-of-care counseling group. Two trained female health educators lead the 2-session HORIZONS intervention which addressed gender and ethnic pride issues, STD/HIV knowledge, assertive partner communication and refusal skills, and role-play practice. Social Cognitive Theory (SCT) and the Theory of Gender and Power were complementary theoretical frameworks guiding the design and implementation of the HIV intervention. To supplement this group intervention, four phone contacts delivered by the original health educator were conducted during the follow-up period. The supplemental contacts reinforced workshop materials with an individually tailored plan for each participant. The control group received tracking calls only. Follow-up assessments identical to the baseline were conducted at 6 and 12-months post-randomization.
- Conditions
- HIV Infections, Sexually Transmitted Diseases
- Being tested
- HORIZONS HIV Intervention, enhanced standard-of-care
- Keywords
- HIV, Sexually Transmitted diseases, Adolescents, Prevention, HIV Seronegativity
- Medical subject headings
- HIV Infections, Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HORIZONS HIV InterventionBehavioural
Two-session, group-based interactive HIV prevention intervention
enhanced standard-of-careBehavioural
1 hour group session consisting of an HIV prevention video, a question and answer session with an African American woman health educator, and participation in a group discussion about how to avoid acquiring HIV.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | HORIZONS HIV Intervention. Two-session, group-based interactive intervention. Receives: Behavioral: HORIZONS HIV Intervention |
| 2 | Active comparator | Enhanced standard-of-care session. One hour, video-based and brief discussion. Receives: Behavioral: enhanced standard-of-care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of condom protected vaginal sex acts over the last 60 days
Measured: 6 and 12 months post-randomization
Secondary outcomes (1)
Incident infection of chlamydia or gonorrhea as confirmed by laboratory PCR testing
Measured: 6 and 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 posted12 Mar 2008 (estimated)
- Study startApr 2002
- Primary completionAug 2004
- Study completionOct 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 715 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Ralph J. DiClemente, Emory University
- Investigators
- Ralph J DiClemente, PhD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00633906
- Sponsor's protocol ID
- IRB00045957
- Other IDs
- MH061210
- Acronym
- HORIZONS
- Status last verified
- Jun 2008
- First submitted
- 5 Mar 2008
- Last updated
- 19 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Sales JM, DiClemente RJ, Rose ES, Wingood GM, Klein JD, Woods ER. Relationship of STD-related shame and stigma to female adolescents' condom-protected intercourse. J Adolesc Health. 2007 Jun;40(6):573.e1-6. doi: 10.1016/j.jadohealth.2007.01.007. Epub 2007 Mar 26.
PubMed 17531767Crosby RA, DiClemente RJ, Wingood GM, Salazar LF, Rose E, Sales JM, Caliendo AM. Oral contraceptive use may not preclude condom use: a study of non-pregnant African-American adolescent females. Sex Transm Infect. 2007 Jun;83(3):216-8. doi: 10.1136/sti.2006.022442.
PubMed 17569720Woods ER, Klein JD, Wingood GM, Rose ES, Wypij D, Harris SK, Diclemente RJ. Development of a new Adolescent Patient-Provider Interaction Scale (APPIS) for youth at risk for STDs/HIV. J Adolesc Health. 2006 Jun;38(6):753.e1-7. doi: 10.1016/j.jadohealth.2005.08.013.
PubMed 16730606Spitalnick JS, DiClemente RJ, Wingood GM, Crosby RA, Milhausen RR, Sales JM, McCarty F, Rose E, Younge SN. Brief report: sexual sensation seeking and its relationship to risky sexual behaviour among African-American adolescent females. J Adolesc. 2007 Feb;30(1):165-73. doi: 10.1016/j.adolescence.2006.10.002. Epub 2006 Nov 30.
PubMed 17140653DiClemente RJ, Wingood GM, Crosby RA, Salazar LF, Rose E, Sales JM, Caliendo AM. Prevalence, correlates, and efficacy of selective avoidance as a sexually transmitted disease prevention strategy among African American adolescent females. Arch Pediatr Adolesc Med. 2008 Jan;162(1):60-5. doi: 10.1001/archpediatrics.2007.5.
PubMed 18180414Salazar LF, Crosby RA, Diclemente RJ, Wingood GM, Rose E, Sales JM, Caliendo AM. Personal, relational, and peer-level risk factors for laboratory confirmed STD prevalence among low-income African American adolescent females. Sex Transm Dis. 2007 Oct;34(10):761-6. doi: 10.1097/01.olq.0000264496.94135.ac.
PubMed 17507835Caliendo AM, Jordan JA, Green AM, Ingersoll J, Diclemente RJ, Wingood GM. Real-time PCR improves detection of Trichomonas vaginalis infection compared with culture using self-collected vaginal swabs. Infect Dis Obstet Gynecol. 2005 Sep;13(3):145-50. doi: 10.1080/10647440500068248.
PubMed 16126499Rosenbaum JE, Zenilman JM, Rose E, Wingood GM, DiClemente RJ. Semen says: assessing the accuracy of adolescents' self-reported sexual abstinence using a semen Y-chromosome biomarker. Sex Transm Infect. 2017 Mar;93(2):145-147. doi: 10.1136/sextrans-2016-052605. Epub 2016 May 4.
PubMed 27147615Swartzendruber A, Brown JL, Sales JM, Murray CC, DiClemente RJ. Sexually transmitted infections, sexual risk behavior, and intimate partner violence among African American adolescent females with a male sex partner recently released from incarceration. J Adolesc Health. 2012 Aug;51(2):156-63. doi: 10.1016/j.jadohealth.2011.11.014. Epub 2012 Feb 28.
PubMed 22824446DiClemente RJ, Wingood GM, Rose ES, Sales JM, Lang DL, Caliendo AM, Hardin JW, Crosby RA. Efficacy of sexually transmitted disease/human immunodeficiency virus sexual risk-reduction intervention for african american adolescent females seeking sexual health services: a randomized controlled trial. Arch Pediatr Adolesc Med. 2009 Dec;163(12):1112-21. doi: 10.1001/archpediatrics.2009.205.
PubMed 19996048
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing HIV Risk in Female Teens: A Tailored Approach
- ClinicalTrials.gov ID
- NCT00633906
- Acronym / sponsor ID
- HORIZONS / IRB00045957
- Conditions
- HIV Infections, Sexually Transmitted Diseases
- Keywords
- HIV, Sexually Transmitted diseases, Adolescents, Prevention, HIV Seronegativity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 715 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Apr 2002
- Primary completion
- Aug 2004 (actual)
- Study completion
- Oct 2005 (actual)
- First posted
- 12 Mar 2008 (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.
The Horizons Program will test the efficacy of a multi-session HIV prevention program for African American female teens attending reproductive health clinics in Atlanta, GA.
Detailed description
African-American adolescent females are a population at high risk for HIV infection. Recent findings suggest that culturally and gender appropriate HIV interventions can significantly reduce HIV-associated sexual risk behaviors among this vulnerable population. The Horizons HIV intervention was developed for African-American female adolescents attending reproductive health clinics in Atlanta, GA. The specific objectives were:
- To evaluate the efficacy of the HORIZONS HIV intervention plus standard of care counseling versus the standard of care counseling alone in reducing self-reported HIV sexual risk behaviors and incident STDs over a 12 month follow-up period.
- To evaluate the cost-effectiveness of the HORIZONS HIV intervention plus standard of care counseling to the standard of care counseling alone with respect to reducing risky sexual behavior and averting incident STDs.
715 participants, ages 15-21, were recruited and enrolled at a large urban county health department, a teen clinic in a public hospital and a reproductive health clinic in the Atlanta area. After a computer interview assessing adolescents' sexual risk and preventive behaviors, and STD testing (Chlamydia and gonorrhea), participants were randomized to one of 2 conditions: the HORIZONS Intervention or the Standard-of-care counseling group. Two trained female health educators lead the 2-session HORIZONS intervention which addressed gender and ethnic pride issues, STD/HIV knowledge, assertive partner communication and refusal skills, and role-play practice. Social Cognitive Theory (SCT) and the Theory of Gender and Power were complementary theoretical frameworks guiding the design and implementation of the HIV intervention. To supplement this group intervention, four phone contacts delivered by the original health educator were conducted during the follow-up period. The supplemental contacts reinforced workshop materials with an individually tailored plan for each participant. The control group received tracking calls only. Follow-up assessments identical to the baseline were conducted at 6 and 12-months post-randomization.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: HORIZONS HIV InterventionHORIZONS HIV Intervention. Two-session, group-based interactive intervention. |
| 2 | Active comparator | Behavioral: enhanced standard-of-careEnhanced standard-of-care session. One hour, video-based and brief discussion. |
Who may qualify
- Ages
- 15 to 21 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Female
- African American
- Ages 15-21
- Receiving care at participating clinic
- Vaginal sex in the past 60 days
Key exclusion criteria (3 listed)
- Married
- Pregnant
- In a detention center
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 HIV InterventionTwo-session, group-based interactive HIV prevention intervention | Behavioural | 1 |
| enhanced standard-of-care1 hour group session consisting of an HIV prevention video, a question and answer session with an African American woman health educator, and participation in a group discussion about how to avoid acquiring HIV. | Behavioural | 2 |
Primary outcome
Proportion of condom protected vaginal sex acts over the last 60 days
Time frame: 6 and 12 months post-randomization
1 secondary outcome
Incident infection of chlamydia or gonorrhea as confirmed by laboratory PCR testing
Time frame: 6 and 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 19 Nov 2013.
- Results publication: PubMed 17531767Sales JM, DiClemente RJ, Rose ES, Wingood GM, Klein JD, Woods ER. Relationship of STD-related shame and stigma to female adolescents' condom-protected intercourse. J Adolesc Health. 2007 Jun;40(6):573.e1-6. doi: 10.1016/j.jadohealth.2007.01.007. Epub 2007 Mar 26.
- Results publication: PubMed 17569720Crosby RA, DiClemente RJ, Wingood GM, Salazar LF, Rose E, Sales JM, Caliendo AM. Oral contraceptive use may not preclude condom use: a study of non-pregnant African-American adolescent females. Sex Transm Infect. 2007 Jun;83(3):216-8. doi: 10.1136/sti.2006.022442.
- Results publication: PubMed 16730606Woods ER, Klein JD, Wingood GM, Rose ES, Wypij D, Harris SK, Diclemente RJ. Development of a new Adolescent Patient-Provider Interaction Scale (APPIS) for youth at risk for STDs/HIV. J Adolesc Health. 2006 Jun;38(6):753.e1-7. doi: 10.1016/j.jadohealth.2005.08.013.
- Results publication: PubMed 17140653Spitalnick JS, DiClemente RJ, Wingood GM, Crosby RA, Milhausen RR, Sales JM, McCarty F, Rose E, Younge SN. Brief report: sexual sensation seeking and its relationship to risky sexual behaviour among African-American adolescent females. J Adolesc. 2007 Feb;30(1):165-73. doi: 10.1016/j.adolescence.2006.10.002. Epub 2006 Nov 30.
- Results publication: PubMed 18180414DiClemente RJ, Wingood GM, Crosby RA, Salazar LF, Rose E, Sales JM, Caliendo AM. Prevalence, correlates, and efficacy of selective avoidance as a sexually transmitted disease prevention strategy among African American adolescent females. Arch Pediatr Adolesc Med. 2008 Jan;162(1):60-5. doi: 10.1001/archpediatrics.2007.5.
- Results publication: PubMed 17507835Salazar LF, Crosby RA, Diclemente RJ, Wingood GM, Rose E, Sales JM, Caliendo AM. Personal, relational, and peer-level risk factors for laboratory confirmed STD prevalence among low-income African American adolescent females. Sex Transm Dis. 2007 Oct;34(10):761-6. doi: 10.1097/01.olq.0000264496.94135.ac.
- Results publication: PubMed 16126499Caliendo AM, Jordan JA, Green AM, Ingersoll J, Diclemente RJ, Wingood GM. Real-time PCR improves detection of Trichomonas vaginalis infection compared with culture using self-collected vaginal swabs. Infect Dis Obstet Gynecol. 2005 Sep;13(3):145-50. doi: 10.1080/10647440500068248.
- Derived from this study: PubMed 27147615Rosenbaum JE, Zenilman JM, Rose E, Wingood GM, DiClemente RJ. Semen says: assessing the accuracy of adolescents' self-reported sexual abstinence using a semen Y-chromosome biomarker. Sex Transm Infect. 2017 Mar;93(2):145-147. doi: 10.1136/sextrans-2016-052605. Epub 2016 May 4.
- Derived from this study: PubMed 22824446Swartzendruber A, Brown JL, Sales JM, Murray CC, DiClemente RJ. Sexually transmitted infections, sexual risk behavior, and intimate partner violence among African American adolescent females with a male sex partner recently released from incarceration. J Adolesc Health. 2012 Aug;51(2):156-63. doi: 10.1016/j.jadohealth.2011.11.014. Epub 2012 Feb 28.
- Derived from this study: PubMed 19996048DiClemente RJ, Wingood GM, Rose ES, Sales JM, Lang DL, Caliendo AM, Hardin JW, Crosby RA. Efficacy of sexually transmitted disease/human immunodeficiency virus sexual risk-reduction intervention for african american adolescent females seeking sexual health services: a randomized controlled trial. Arch Pediatr Adolesc Med. 2009 Dec;163(12):1112-21. doi: 10.1001/archpediatrics.2009.205.
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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
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HORIZONS HIV Intervention and enhanced standard-of-care in people with HIV Infections and Sexually Transmitted Diseases, run by Emory University at 3 sites 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 6 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 19 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Proportion of condom protected vaginal sex acts over the last 60 days (time frame: 6 and 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 NCT00633906, which also lists 10 linked publications.
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 19 Nov 2013.