Sexually Transmitted DiseasesPhase 3NCT00279799
HIV Prevention for African American Teens
A Phase 3 study testing Afiya HIV Prevention Intervention in people with Sexually Transmitted Diseases, run by Emory University at 3 sites in United States.
Trial summary
AFIYA aims to reduce both the risk of Sexually Transmitted Infections (STIs) and HIV in young African American females through a culturally and gender appropriate intervention (group sessions) coupled with an individualized HIV Telephone Maintenance Intervention. Read more about this study
- Who is it for?
- Ages 14 to 20 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sexually Transmitted Diseases
- What is being tested?
- Afiya HIV Prevention Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 701 participants
- Where
- 3 sitesUnited States
- Study dates
- Feb 2005to Feb 2013
- Phase
- Phase 3
- 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 14 to 20 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Female; African American; age 14-20; receiving care at participating clinic;report having unprotected vaginal sex in last 6 months; ability to give written informed consent
Who cannot join
- pregnant or trying to get pregnant; married; any condition that would preclude attending group-based intervention sessions.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Fulton County Department of Health and Wellness
Atlanta, Georgia, 30303
Grady Hospital Teen Clinic
Atlanta, Georgia, 30303
Planned Parenthood of GA
Atlanta, Georgia, 30303
About this study
Official title: HIV Prevention Maintenance for African American Teens
AFIYA aims to reduce both the risk of Sexually Transmitted Infections (STIs) and HIV in young African American females through a culturally and gender appropriate intervention (group sessions) coupled with an individualized HIV Telephone Maintenance Intervention.
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 educational programs can significantly reduce sexual risk behaviors among this vulnerable population over the short term. It is unclear as to whether these programs have long-term effects. Thus, the aim of this project is to develop and test a culturally and gender-appropriate sexual health education program designed to promote long-term maintenance of HIV preventive sexual behaviors over a long follow-up period.
700 African-American female adolescents' between the ages of 14-20 will be enrolled in this trial. Adolescents will be recruited from youth currently seeking services at several family planning clinics in Atlanta, Georgia. Adolescents who are eligible and willing to participate in the project will complete an initial ACASI survey. The survey is designed to assess adolescents' sexual risk and preventive behaviors. Biological specimens are collected and tested for common STI's. Free DOT (Directly Observed Therapy) is provided through the clinics. Urine pregnancy screens will also be conducted. After they complete the assessment, adolescents will receive a sexual health education program that was developed by the Principal Investigator. This program (HORIZONS) has been shown to be effective in reducing sexual risk behaviors over the short-term. Trained African American female health educators will deliver the sexual health education program. Adolescents will then be assigned, by chance alone, to one of two groups: one group will get periodic telephone contacts designed to reinforce sexual health promotion and the other group will get periodic telephone contacts that promote healthy dietary practices. Thus, while all adolescents receive the same sexual health education program, half will get telephone calls emphasizing sexual health and half will get an equal number of telephone calls emphasizing nutritional health.
The primary aims of the proposed project are:
Primary Aim 1. To determine whether adding a telephone educational component to a sexual health education program will reduce incident STD infection over a 36-month follow-up.
Primary Aim 2. To determine if adding a telephone educational component to a sexual health education program can maintain HIV-preventive behaviors.
We will ask adolescents to come back to participating clinics to complete follow-up assessments at 6 months, 12-months,18-months, 24-months, 30-months and 36-months after completing the initial assessment. We will test the effects of adding the telephone sexual health educational program to maintain or enhance adolescents' use of HIV prevention behaviors and reduce incident STDs. If successful, the findings could have important implications for HIV prevention.
- Conditions
- Sexually Transmitted Diseases
- Being tested
- Afiya HIV Prevention Intervention
- Keywords
- Sexually Transmitted Diseases, HIV, condom use, adolescents
- 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.
Afiya HIV Prevention InterventionBehavioural
Group-based session plus individually tailored HIV prevention phone sessions
Afiya HIV prevention interventionBehavioural
Afiya group-based intervention + nutrition phone sessions (attention control)
| Study group | Role | What they receive |
|---|---|---|
| Afiya group intervention + HIV prevention phone sessions | Experimental | Afiya group-based intervention plus individually tailored HIV prevention phone sessions Receives: Behavioral: Afiya HIV Prevention Intervention |
| Afiya group session + nutrition phone sessions | Active comparator | Afiya group-based intervention plus individually tailored nutrition phone sessions Receives: Behavioral: Afiya HIV prevention intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incident STD infection, particularly chlamydial infections, confirmed by laboratory PRC testing over a 36 month follow-up.
Measured: 36 months post-randomization.
Secondary outcomes (1)
Proportion of condom-protected vaginal sex acts and sex while high or drunk over the 36 month follow-up.
Measured: 36 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 posted20 Jan 2006 (estimated)
- Study startFeb 2005
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 701 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
- NCT00279799
- Sponsor's protocol ID
- IRB00041131
- Other IDs
- NIMH 5 R01 MH070537-08
- Status last verified
- Sep 2013
- First submitted
- 18 Jan 2006
- Last updated
- 19 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
DePadilla L, Windle M, Wingood G, Cooper H, DiClemente R. Condom use among young women: modeling the theory of gender and power. Health Psychol. 2011 May;30(3):310-9. doi: 10.1037/a0022871.
PubMed 21553975Sales JM, Latham TP, Diclemente RJ, Rose E. Differences between dual-method and non-dual-method protection use in a sample of young African American women residing in the Southeastern United States. Arch Pediatr Adolesc Med. 2010 Dec;164(12):1125-31. doi: 10.1001/archpediatrics.2010.230.
PubMed 21135341Sales JM, Lang DL, DiClemente RJ, Latham TP, Wingood GM, Hardin JW, Rose ES. The mediating role of partner communication frequency on condom use among African American adolescent females participating in an HIV prevention intervention. Health Psychol. 2012 Jan;31(1):63-9. doi: 10.1037/a0025073. Epub 2011 Aug 15.
PubMed 21843001Sales JM, Brown JL, Diclemente RJ, Davis TL, Kottke MJ, Rose ES. Age differences in STDs, sexual behaviors, and correlates of risky sex among sexually experienced adolescent African-American females. J Pediatr Psychol. 2012 Jan-Feb;37(1):33-42. doi: 10.1093/jpepsy/jsr076. Epub 2011 Sep 20.
PubMed 21933811Diclemente RJ, Young AM, Painter JL, Wingood GM, Rose E, Sales JM. Prevalence and correlates of recent vaginal douching among African American adolescent females. J Pediatr Adolesc Gynecol. 2012 Feb;25(1):48-53. doi: 10.1016/j.jpag.2011.07.017. Epub 2011 Nov 3.
PubMed 22051790Brown JL, Sales JM, Diclemente RJ, Latham Davis TP, Rose ES. Characteristics of African American adolescent females who perceive their current boyfriends have concurrent sexual partners. J Adolesc Health. 2012 Apr;50(4):377-82. doi: 10.1016/j.jadohealth.2011.07.008. Epub 2011 Sep 23.
PubMed 22443842Sales JM, DiClemente RJ, Brody GH, Philibert RA, Rose E. Interaction between 5-HTTLPR polymorphism and abuse history on adolescent African-American females' condom use behavior following participation in an HIV prevention intervention. Prev Sci. 2014 Jun;15(3):257-67. doi: 10.1007/s11121-013-0378-6.
PubMed 23479192DiClemente RJ, Wingood GM, Sales JM, Brown JL, Rose ES, Davis TL, Lang DL, Caliendo A, Hardin JW. Efficacy of a telephone-delivered sexually transmitted infection/human immunodeficiency virus prevention maintenance intervention for adolescents: a randomized clinical trial. JAMA Pediatr. 2014 Oct;168(10):938-46. doi: 10.1001/jamapediatrics.2014.1436.
PubMed 25155070Swartzendruber A, Sales JM, Brown JL, Davis TL, DiClemente RJ, Rose E. Predictors of repeat Chlamydia trachomatis and/or Neisseria gonorrhoeae infections among African-American adolescent women. Sex Transm Infect. 2013 Feb;89(1):76-82. doi: 10.1136/sextrans-2012-050530. Epub 2012 Dec 12.
PubMed 23236082
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
- HIV Prevention Maintenance for African American Teens
- ClinicalTrials.gov ID
- NCT00279799
- Acronym / sponsor ID
- IRB00041131
- Conditions
- Sexually Transmitted Diseases
- Keywords
- Sexually Transmitted Diseases, HIV, condom use, adolescents
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 701 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Feb 2005
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 20 Jan 2006 (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.
AFIYA aims to reduce both the risk of Sexually Transmitted Infections (STIs) and HIV in young African American females through a culturally and gender appropriate intervention (group sessions) coupled with an individualized HIV Telephone Maintenance Intervention.
Detailed description
African-American adolescent females are a population at high risk for HIV infection. Recent findings suggest that culturally and gender appropriate HIV educational programs can significantly reduce sexual risk behaviors among this vulnerable population over the short term. It is unclear as to whether these programs have long-term effects. Thus, the aim of this project is to develop and test a culturally and gender-appropriate sexual health education program designed to promote long-term maintenance of HIV preventive sexual behaviors over a long follow-up period.
700 African-American female adolescents' between the ages of 14-20 will be enrolled in this trial. Adolescents will be recruited from youth currently seeking services at several family planning clinics in Atlanta, Georgia. Adolescents who are eligible and willing to participate in the project will complete an initial ACASI survey. The survey is designed to assess adolescents' sexual risk and preventive behaviors. Biological specimens are collected and tested for common STI's. Free DOT (Directly Observed Therapy) is provided through the clinics. Urine pregnancy screens will also be conducted. After they complete the assessment, adolescents will receive a sexual health education program that was developed by the Principal Investigator. This program (HORIZONS) has been shown to be effective in reducing sexual risk behaviors over the short-term. Trained African American female health educators will deliver the sexual health education program. Adolescents will then be assigned, by chance alone, to one of two groups: one group will get periodic telephone contacts designed to reinforce sexual health promotion and the other group will get periodic telephone contacts that promote healthy dietary practices. Thus, while all adolescents receive the same sexual health education program, half will get telephone calls emphasizing sexual health and half will get an equal number of telephone calls emphasizing nutritional health.
The primary aims of the proposed project are:
Primary Aim 1. To determine whether adding a telephone educational component to a sexual health education program will reduce incident STD infection over a 36-month follow-up.
Primary Aim 2. To determine if adding a telephone educational component to a sexual health education program can maintain HIV-preventive behaviors.
We will ask adolescents to come back to participating clinics to complete follow-up assessments at 6 months, 12-months,18-months, 24-months, 30-months and 36-months after completing the initial assessment. We will test the effects of adding the telephone sexual health educational program to maintain or enhance adolescents' use of HIV prevention behaviors and reduce incident STDs. If successful, the findings could have important implications for HIV prevention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Afiya group intervention + HIV prevention phone sessions | Experimental | Behavioral: Afiya HIV Prevention InterventionAfiya group-based intervention plus individually tailored HIV prevention phone sessions |
| Afiya group session + nutrition phone sessions | Active comparator | Behavioral: Afiya HIV prevention interventionAfiya group-based intervention plus individually tailored nutrition phone sessions |
Who may qualify
- Ages
- 14 to 20 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Female; African American; age 14-20; receiving care at participating clinic;report having unprotected vaginal sex in last 6 months; ability to give written informed consent
Key exclusion criteria (1 listed)
- pregnant or trying to get pregnant; married; any condition that would preclude attending group-based intervention sessions.
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 |
|---|---|---|
| Afiya HIV Prevention InterventionGroup-based session plus individually tailored HIV prevention phone sessions | Behavioural | Afiya group intervention + HIV prevention phone sessions |
| Afiya HIV prevention interventionAfiya group-based intervention + nutrition phone sessions (attention control) | Behavioural | Afiya group session + nutrition phone sessions |
Primary outcome
Incident STD infection, particularly chlamydial infections, confirmed by laboratory PRC testing over a 36 month follow-up.
Time frame: 36 months post-randomization.
1 secondary outcome
Proportion of condom-protected vaginal sex acts and sex while high or drunk over the 36 month follow-up.
Time frame: 36 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.
- Background: PubMed 21553975DePadilla L, Windle M, Wingood G, Cooper H, DiClemente R. Condom use among young women: modeling the theory of gender and power. Health Psychol. 2011 May;30(3):310-9. doi: 10.1037/a0022871.
- Background: PubMed 21135341Sales JM, Latham TP, Diclemente RJ, Rose E. Differences between dual-method and non-dual-method protection use in a sample of young African American women residing in the Southeastern United States. Arch Pediatr Adolesc Med. 2010 Dec;164(12):1125-31. doi: 10.1001/archpediatrics.2010.230.
- Background: PubMed 21843001Sales JM, Lang DL, DiClemente RJ, Latham TP, Wingood GM, Hardin JW, Rose ES. The mediating role of partner communication frequency on condom use among African American adolescent females participating in an HIV prevention intervention. Health Psychol. 2012 Jan;31(1):63-9. doi: 10.1037/a0025073. Epub 2011 Aug 15.
- Background: PubMed 21933811Sales JM, Brown JL, Diclemente RJ, Davis TL, Kottke MJ, Rose ES. Age differences in STDs, sexual behaviors, and correlates of risky sex among sexually experienced adolescent African-American females. J Pediatr Psychol. 2012 Jan-Feb;37(1):33-42. doi: 10.1093/jpepsy/jsr076. Epub 2011 Sep 20.
- Background: PubMed 22051790Diclemente RJ, Young AM, Painter JL, Wingood GM, Rose E, Sales JM. Prevalence and correlates of recent vaginal douching among African American adolescent females. J Pediatr Adolesc Gynecol. 2012 Feb;25(1):48-53. doi: 10.1016/j.jpag.2011.07.017. Epub 2011 Nov 3.
- Background: PubMed 22443842Brown JL, Sales JM, Diclemente RJ, Latham Davis TP, Rose ES. Characteristics of African American adolescent females who perceive their current boyfriends have concurrent sexual partners. J Adolesc Health. 2012 Apr;50(4):377-82. doi: 10.1016/j.jadohealth.2011.07.008. Epub 2011 Sep 23.
- Background: PubMed 23479192Sales JM, DiClemente RJ, Brody GH, Philibert RA, Rose E. Interaction between 5-HTTLPR polymorphism and abuse history on adolescent African-American females' condom use behavior following participation in an HIV prevention intervention. Prev Sci. 2014 Jun;15(3):257-67. doi: 10.1007/s11121-013-0378-6.
- Derived from this study: PubMed 25155070DiClemente RJ, Wingood GM, Sales JM, Brown JL, Rose ES, Davis TL, Lang DL, Caliendo A, Hardin JW. Efficacy of a telephone-delivered sexually transmitted infection/human immunodeficiency virus prevention maintenance intervention for adolescents: a randomized clinical trial. JAMA Pediatr. 2014 Oct;168(10):938-46. doi: 10.1001/jamapediatrics.2014.1436.
- Derived from this study: PubMed 23236082Swartzendruber A, Sales JM, Brown JL, Davis TL, DiClemente RJ, Rose E. Predictors of repeat Chlamydia trachomatis and/or Neisseria gonorrhoeae infections among African-American adolescent women. Sex Transm Infect. 2013 Feb;89(1):76-82. doi: 10.1136/sextrans-2012-050530. Epub 2012 Dec 12.
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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 Phase 3 study testing Afiya HIV Prevention Intervention in people with 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 1 inclusion and 1 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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, particularly chlamydial infections, confirmed by laboratory PRC testing over a 36 month follow-up. (time frame: 36 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 NCT00279799, which also lists 9 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.