HIV InfectionPhase 2NCT00161343
Maintaining HIV Prevention Gains in Female Adolescents
A Phase 2 study testing Health Improvement Project for Teens on HIV Prevention in people with HIV Infection and Sexually Transmitted Diseases, run by University of Rochester at 1 site in United States.
Trial summary
In this study, an intervention is tested that is designed to reduced risky sexual behaviors in adolescent females. Study design: randomized, controlled study participants: 640 girls aged 15-19 years old length of follow-up: 1 year after the intervention is completed Study hypothesis: The experimental condition will… Read more about this study
- Who is it for?
- Ages 15 to 19 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Infection, Sexually Transmitted Diseases
- What is being tested?
- Health Improvement Project for Teens on HIV Prevention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 640 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2004to Aug 2009
- Phase
- Phase 2
- 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 19 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 15-19 years old
- Sexually active in the past 3 months
- Available for follow-up contacts over the next 13 months
- English speaking
Who cannot join
- Pregnant, or had a baby in the last 3 months
- Married or living with a partner
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Rochester School of Nursing
Rochester, New York, 14642
About this study
Official title: Randomized Controlled Trial of an Group Intervention to Maintain HIV Prevention Gains in Female Adolescents
In this study, an intervention is tested that is designed to reduced risky sexual behaviors in adolescent females. Study design:
- randomized, controlled study
- participants: 640 girls aged 15-19 years old
- length of follow-up: 1 year after the intervention is completed
Read more
Study hypothesis: The experimental condition will significantly reduce risky sexual behaviors in adolescent females as measured by:
- lower incidence of STI's at 6 and 12 months, as compared to baseline
- decreased incidence of risky sexual behaviors
- increased knowledge of the level of risk of certain behaviors
- increased knowledge of safer sexual behaviors that can prevention HIV infection
- increased motivation to reduce sexual risk
- increased behavioral skills to reduce risk of HIV infection
Read the detailed description
Adolescence is the only age category where the number of females infected with HIV outnumber the number of males. Despite these data, only three randomized controlled trials have evaluated the efficacy of a gender-specific HIV-risk reduction program for adolescent females. The proposed research aims to address this gap in HIV prevention science, and will evaluate the short and longer-term efficacy of a HIV-prevention intervention for adolescent girls. We will recruit 640 adolescent females aged 15 to 19 years from family planning clinics and randomly assign them to one of two conditions: (a) an HIV-risk reduction intervention based on the Information-Motivation-Behavioral Skills (IMB) model (Fisher \& Fisher, 1992) or (b) a structurally equivalent health promotion control group (CTL) both supplemented by booster sessions at 3 and 6 months. At a short-term (3-month) follow-up, we hypothesize that IMB participants will increase HIV-related knowledge, motivation, and behavioral skills, and decrease the frequency of risky sexual practices relative to CTL participants. We will reassess all participants at 6 and 12 months to evaluate the longer-term efficacy of the interventions. At these longer-term follow-ups, we hypothesize that IMB participants will demonstrate higher levels of HIV knowledge, motivation, and behavioral skills; decreased risky sexual practices; and decreased rates of STDs (Chlamydia, gonorrhea) relative to the CTL participants. The final aim of the proposed research is to determine whether the constructs in the Information-Motivation-Behavioral Skills (IMB) Model (Fisher \& Fisher, 1992), can account for variability in HIV-related behavior. We hypothesize that preventive behavior at 6 and 12 months will be a function of a participant's HIV-related information, motivation, and behavioral skills at the 3-month follow-up, and that information and motivation will be partially mediated by behavioral skills to influence the initiation and maintenance of HIV preventive behavior. The long-term intent of the proposed research is to develop a risk reduction program that can be used by community-based health organizations to reduce the risk of HIV infection among adolescent females.
- Conditions
- HIV Infection, Sexually Transmitted Diseases
- Being tested
- Health Improvement Project for Teens on HIV Prevention
- Keywords
- HIV, Prevention Intervention, Female, Adolescents, STD, 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.
Health Improvement Project for Teens on HIV PreventionBehavioural
Also called HIP Teens
Comparison of 2 facilitator-led intervention groups: (1) HIV prevention, and (2) general health promotion. Outcome measures: sexual risk behaviors in adolescent girls
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Small interactive groups on preventing HIV infections using an Information-Behavioral Skills-Motivational model Receives: Behavioral: Health Improvement Project for Teens on HIV Prevention |
| 2 | Placebo comparator | Small interactive groups on general health-promotion topics using an Information-Behavioral Skills-Motivational model Receives: Behavioral: Health Improvement Project for Teens on HIV Prevention |
What is being measured
The primary outcome is the main question the study is designed to answer.
rates of STIs
Measured: Baseline, 6 and 12 months
computer-assisted survey results
Measured: baseline, 1 week, 3, 6, & 12 months
- score on self-report of frequency of risky sexual and substance use behaviors
Measured: baseline, 1 week, 3, 6, & 12 months
Secondary outcomes (1)
- score on assessments of information, motivation, and behavioral skills to reduce risk for HIV
Measured: baseline, 3, 6, & 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startDec 2004
- Primary completionAug 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionStudies of the same condition, open and under way.
- More trials run by University of RochesterThe 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 640 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Principal investigator, Dianne Morrison-Beedy, University of Rochester
- Investigators
- Dianne C. Morrison-Beedy, Ph.D., RN, Principal investigator, University of Rochester School of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00161343
- Sponsor's protocol ID
- R01NR008194
- Status last verified
- Apr 2009
- First submitted
- 8 Sep 2005
- Last updated
- 6 Sep 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Morrison-Beedy D, Aronowitz T, Dyne J, Mkandawire L, Murphy C, Martin J. The nurse clinician as research participant recruiter: experience from a longitudinal intervention study. J N Y State Nurses Assoc. 2001 Fall-Winter;32(2):9-13.
PubMed 16052902Morrison-Beedy D, Carey MP, Kowalski J, Tu X. Group-based HIV risk reduction intervention for adolescent girls: evidence of feasibility and efficacy. Res Nurs Health. 2005 Feb;28(1):3-15. doi: 10.1002/nur.20056.
PubMed 15625713Morrison-Beedy D, Carey MP, Aronowitz T. Psychosocial correlates of HIV risk behavior in adolescent girls. J Obstet Gynecol Neonatal Nurs. 2003 Jan-Feb;32(1):94-101. doi: 10.1177/0884217502239806.
PubMed 12570188Morrison-Beedy D, Carey MP, Aronowitz T, Mkandawire L, Dyne J. An HIV risk-reduction intervention in an adolescent correctional facility: lessons learned. Appl Nurs Res. 2002 May;15(2):97-101. doi: 10.1053/apnr.2002.29530.
PubMed 11994826Morrison-Beedy D, Carey MP, Aronowitz T, Mkandawire L, Dyne J. Adolescents' input on the development of an HIV risk reduction intervention. J Assoc Nurses AIDS Care. 2002 Jan-Feb;13(1):21-7. doi: 10.1016/S1055-3290(06)60238-0.
PubMed 11828857Morrison-Beedy D, Crean HF, Passmore D, Carey MP. Risk reduction strategies used by urban adolescent girls in an HIV prevention trial. Curr HIV Res. 2013 Oct;11(7):559-69. doi: 10.2174/1570162x12666140129110129.
PubMed 24476350Morrison-Beedy D, Jones SH, Xia Y, Tu X, Crean HF, Carey MP. Reducing sexual risk behavior in adolescent girls: results from a randomized controlled trial. J Adolesc Health. 2013 Mar;52(3):314-21. doi: 10.1016/j.jadohealth.2012.07.005. Epub 2012 Aug 28.
PubMed 23299011
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of an Group Intervention to Maintain HIV Prevention Gains in Female Adolescents
- ClinicalTrials.gov ID
- NCT00161343
- Acronym / sponsor ID
- R01NR008194
- Conditions
- HIV Infection, Sexually Transmitted Diseases
- Keywords
- HIV, Prevention Intervention, Female, Adolescents, STD, HIV Seronegativity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 640 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- Dec 2004
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 12 Sep 2005 (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.
In this study, an intervention is tested that is designed to reduced risky sexual behaviors in adolescent females. Study design:
- randomized, controlled study
- participants: 640 girls aged 15-19 years old
- length of follow-up: 1 year after the intervention is completed
Study hypothesis: The experimental condition will significantly reduce risky sexual behaviors in adolescent females as measured by:
- lower incidence of STI's at 6 and 12 months, as compared to baseline
- decreased incidence of risky sexual behaviors
- increased knowledge of the level of risk of certain behaviors
- increased knowledge of safer sexual behaviors that can prevention HIV infection
- increased motivation to reduce sexual risk
- increased behavioral skills to reduce risk of HIV infection
Detailed description
Adolescence is the only age category where the number of females infected with HIV outnumber the number of males. Despite these data, only three randomized controlled trials have evaluated the efficacy of a gender-specific HIV-risk reduction program for adolescent females. The proposed research aims to address this gap in HIV prevention science, and will evaluate the short and longer-term efficacy of a HIV-prevention intervention for adolescent girls. We will recruit 640 adolescent females aged 15 to 19 years from family planning clinics and randomly assign them to one of two conditions: (a) an HIV-risk reduction intervention based on the Information-Motivation-Behavioral Skills (IMB) model (Fisher \& Fisher, 1992) or (b) a structurally equivalent health promotion control group (CTL) both supplemented by booster sessions at 3 and 6 months. At a short-term (3-month) follow-up, we hypothesize that IMB participants will increase HIV-related knowledge, motivation, and behavioral skills, and decrease the frequency of risky sexual practices relative to CTL participants. We will reassess all participants at 6 and 12 months to evaluate the longer-term efficacy of the interventions. At these longer-term follow-ups, we hypothesize that IMB participants will demonstrate higher levels of HIV knowledge, motivation, and behavioral skills; decreased risky sexual practices; and decreased rates of STDs (Chlamydia, gonorrhea) relative to the CTL participants. The final aim of the proposed research is to determine whether the constructs in the Information-Motivation-Behavioral Skills (IMB) Model (Fisher \& Fisher, 1992), can account for variability in HIV-related behavior. We hypothesize that preventive behavior at 6 and 12 months will be a function of a participant's HIV-related information, motivation, and behavioral skills at the 3-month follow-up, and that information and motivation will be partially mediated by behavioral skills to influence the initiation and maintenance of HIV preventive behavior. The long-term intent of the proposed research is to develop a risk reduction program that can be used by community-based health organizations to reduce the risk of HIV infection among adolescent females.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Health Improvement Project for Teens on HIV PreventionSmall interactive groups on preventing HIV infections using an Information-Behavioral Skills-Motivational model |
| 2 | Placebo comparator | Behavioral: Health Improvement Project for Teens on HIV PreventionSmall interactive groups on general health-promotion topics using an Information-Behavioral Skills-Motivational model |
Who may qualify
- Ages
- 15 to 19 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 15-19 years old
- Sexually active in the past 3 months
- Available for follow-up contacts over the next 13 months
- English speaking
Key exclusion criteria (2 listed)
- Pregnant, or had a baby in the last 3 months
- Married or living with a partner
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 |
|---|---|---|
| Health Improvement Project for Teens on HIV PreventionAlso: HIP TeensComparison of 2 facilitator-led intervention groups: (1) HIV prevention, and (2) general health promotion. Outcome measures: sexual risk behaviors in adolescent girls | Behavioural | 1, 2 |
Primary outcome
rates of STIs
Time frame: Baseline, 6 and 12 months
computer-assisted survey results
Time frame: baseline, 1 week, 3, 6, & 12 months
- score on self-report of frequency of risky sexual and substance use behaviors
Time frame: baseline, 1 week, 3, 6, & 12 months
1 secondary outcome
- score on assessments of information, motivation, and behavioral skills to reduce risk for HIV
Time frame: baseline, 3, 6, & 12 months
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 6 Sep 2012.
- Background: PubMed 16052902Morrison-Beedy D, Aronowitz T, Dyne J, Mkandawire L, Murphy C, Martin J. The nurse clinician as research participant recruiter: experience from a longitudinal intervention study. J N Y State Nurses Assoc. 2001 Fall-Winter;32(2):9-13.
- Background: PubMed 15625713Morrison-Beedy D, Carey MP, Kowalski J, Tu X. Group-based HIV risk reduction intervention for adolescent girls: evidence of feasibility and efficacy. Res Nurs Health. 2005 Feb;28(1):3-15. doi: 10.1002/nur.20056.
- Background: PubMed 12570188Morrison-Beedy D, Carey MP, Aronowitz T. Psychosocial correlates of HIV risk behavior in adolescent girls. J Obstet Gynecol Neonatal Nurs. 2003 Jan-Feb;32(1):94-101. doi: 10.1177/0884217502239806.
- Background: PubMed 11994826Morrison-Beedy D, Carey MP, Aronowitz T, Mkandawire L, Dyne J. An HIV risk-reduction intervention in an adolescent correctional facility: lessons learned. Appl Nurs Res. 2002 May;15(2):97-101. doi: 10.1053/apnr.2002.29530.
- Background: PubMed 11828857Morrison-Beedy D, Carey MP, Aronowitz T, Mkandawire L, Dyne J. Adolescents' input on the development of an HIV risk reduction intervention. J Assoc Nurses AIDS Care. 2002 Jan-Feb;13(1):21-7. doi: 10.1016/S1055-3290(06)60238-0.
- Derived from this study: PubMed 24476350Morrison-Beedy D, Crean HF, Passmore D, Carey MP. Risk reduction strategies used by urban adolescent girls in an HIV prevention trial. Curr HIV Res. 2013 Oct;11(7):559-69. doi: 10.2174/1570162x12666140129110129.
- Derived from this study: PubMed 23299011Morrison-Beedy D, Jones SH, Xia Y, Tu X, Crean HF, Carey MP. Reducing sexual risk behavior in adolescent girls: results from a randomized controlled trial. J Adolesc Health. 2013 Mar;52(3):314-21. doi: 10.1016/j.jadohealth.2012.07.005. Epub 2012 Aug 28.
Related trials for HIV Infection
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
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.
Dianne C. Morrison-Beedy, Ph.D., RN principal investigator
University of Rochester School of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Health Improvement Project for Teens on HIV Prevention in people with HIV Infection and Sexually Transmitted Diseases, run by University of Rochester 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 4 inclusion and 2 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 6 Sep 2012. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
rates of STIs (time frame: Baseline, 6 and 12 months). The study lists 3 primary outcomes in all. 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 NCT00161343, which also lists 7 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 6 Sep 2012.