HIV InfectionsNCT00653575
Adult Sexual Risk Behavior Among Women With a History of Childhood Sexual Abuse
An observational study of HIV Infections and Child Abuse, Sexual, run by Syracuse University at 1 site in United States.
Trial summary
This study will evaluate whether childhood experiences are related to current sexual behavior of adult women. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Infections, Child Abuse, Sexual
- What is being tested?
- Information-Motivation-Behavioral Skills model and Traumagenic Dynamics model
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 481 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2008to Jun 2010
- Phase
- Observational
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: This study will include women seeking treatment at the Monroe County Health Department STD Clinic.
Who may be able to join
- Understands English
Who cannot join
- Impaired mentally
Trial locations and contacts
1 site in 1 country.
United States1 site
Monroe County Health Department STD Clinic
Rochester, New York, 14611
About this study
Official title: HIV Risk Among Women With a History of Childhood Sexual Abuse
This study will evaluate whether childhood experiences are related to current sexual behavior of adult women.
Read the detailed description
Adverse childhood events, including physical and sexual abuse, can cause significant distress for those affected, during both childhood and adulthood. Childhood abuse appears to increase the risk of a number of negative outcomes later in life, including psychiatric disorders, substance abuse, and HIV and sexually transmitted infections. Previous research has consistently found an association between childhood sexual abuse and greater rates of adult sexual risk behavior. However, improved understanding of how childhood sexual abuse relates to adult sexual risk behavior is needed. The Information-Motivation-Behavioral Skills and Traumagenic Dynamics models are theories used to investigate determinants of sexual behavior and effects of childhood abuse. Using these models to examine the relationship between childhood sexual abuse and adult sexual risk behavior may help in creating effective sexual risk reduction interventions for women abused during childhood. This study will evaluate whether childhood experiences are related to current sexual behavior of adult women. The study will also evaluate which theory, the Information-Motivation-Behavioral Skills model or the Traumagenic Dynamics model, better mediates the relationship between childhood sexual abuse and adult sexual risk behavior.
Participation in this study will include one study visit. Participants will first complete a 45-minute computerized survey that includes questions about childhood experiences; family environment; current health and behavior; attitudes, knowledge, and thoughts about sex and relationships; control over life circumstances; and substance use. Participants will then engage in two brief role plays in which they will either make a request of their partner or must stand up for themselves. For the last part of the visit, participants will be asked questions about condoms and condom use and will be asked to place a condom on a model used in the clinic.
- Conditions
- HIV Infections, Child Abuse, Sexual
- Being tested
- Information-Motivation-Behavioral Skills model, Traumagenic Dynamics model
- Keywords
- Sexual Behavior, HIV, Sexually Transmitted Diseases
- Medical subject headings
- HIV Infections, Coitus, Sexual Behavior, Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Information-Motivation-Behavioral Skills modelBehavioural
The Information-Motivation-Behavioral Skills model is an influential and empirically supported theory of health behavior. The model suggests that HIV-related information, motivation, and behavioral skills are important determinants of sexual behavior; thus, childhood sexual abuse may lead to deficits in these areas. This model will be used to guide research interviews.
Traumagenic Dynamics modelBehavioural
The Traumagenic Dynamics model is an influential and empirically supported model of the effects of childhood sexual abuse. The model suggests that childhood sexual abuse leads to traumatic sexualization, stigmatization, betrayal, and powerlessness and that these four traumagenic dynamics lead to adverse outcomes, including increased rates of sexual risk behavior. This model will be used to guide research interviews.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Women who report a history of childhood sexual abuse Receives: Behavioral: Information-Motivation-Behavioral Skills model; Behavioral: Traumagenic Dynamics model | |
| 2 | Women who do not report a history of childhood sexual abuse Receives: Behavioral: Information-Motivation-Behavioral Skills model; Behavioral: Traumagenic Dynamics model |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of sexual partners
Measured: Measured at Month 3
Secondary outcomes (2)
Frequency of unprotected intercourse
Measured: Measured at Month 3
Proportion of episodes of unprotected intercourse
Measured: Measured at Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2008 (estimated)
- Study startAug 2008
- Primary completionJun 2010
- Study completionJun 2010
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.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 481 participants (actual)
Sponsor and investigators
- Lead sponsor
- Syracuse University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Investigators
- Theresa E. Senn, PhD, Principal investigator, Syracuse University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00653575
- Sponsor's protocol ID
- R21MH083502
- Other IDs
- R21MH083502, DAHBR 9A-ASPQ
- Status last verified
- Apr 2013
- First submitted
- 3 Apr 2008
- Last updated
- 15 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HIV Risk Among Women With a History of Childhood Sexual Abuse
- ClinicalTrials.gov ID
- NCT00653575
- Acronym / sponsor ID
- R21MH083502
- Conditions
- HIV Infections, Child Abuse, Sexual
- Keywords
- Sexual Behavior, HIV, Sexually Transmitted Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 481 participants (actual)
- Lead sponsor
- Syracuse UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Aug 2008
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 7 Apr 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.
This study will evaluate whether childhood experiences are related to current sexual behavior of adult women.
Detailed description
Adverse childhood events, including physical and sexual abuse, can cause significant distress for those affected, during both childhood and adulthood. Childhood abuse appears to increase the risk of a number of negative outcomes later in life, including psychiatric disorders, substance abuse, and HIV and sexually transmitted infections. Previous research has consistently found an association between childhood sexual abuse and greater rates of adult sexual risk behavior. However, improved understanding of how childhood sexual abuse relates to adult sexual risk behavior is needed. The Information-Motivation-Behavioral Skills and Traumagenic Dynamics models are theories used to investigate determinants of sexual behavior and effects of childhood abuse. Using these models to examine the relationship between childhood sexual abuse and adult sexual risk behavior may help in creating effective sexual risk reduction interventions for women abused during childhood. This study will evaluate whether childhood experiences are related to current sexual behavior of adult women. The study will also evaluate which theory, the Information-Motivation-Behavioral Skills model or the Traumagenic Dynamics model, better mediates the relationship between childhood sexual abuse and adult sexual risk behavior.
Participation in this study will include one study visit. Participants will first complete a 45-minute computerized survey that includes questions about childhood experiences; family environment; current health and behavior; attitudes, knowledge, and thoughts about sex and relationships; control over life circumstances; and substance use. Participants will then engage in two brief role plays in which they will either make a request of their partner or must stand up for themselves. For the last part of the visit, participants will be asked questions about condoms and condom use and will be asked to place a condom on a model used in the clinic.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Behavioral: Information-Motivation-Behavioral Skills model, Behavioral: Traumagenic Dynamics modelWomen who report a history of childhood sexual abuse |
| 2 | – | Behavioral: Information-Motivation-Behavioral Skills model, Behavioral: Traumagenic Dynamics modelWomen who do not report a history of childhood sexual abuse |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This study will include women seeking treatment at the Monroe County Health Department STD Clinic.
Key inclusion criteria (1 listed)
- Understands English
Key exclusion criteria (1 listed)
- Impaired mentally
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 |
|---|---|---|
| Information-Motivation-Behavioral Skills modelThe Information-Motivation-Behavioral Skills model is an influential and empirically supported theory of health behavior. The model suggests that HIV-related information, motivation, and behavioral skills are important determinants of sexual behavior; thus, childhood sexual abuse may lead to deficits in these areas. This model will be used to guide research interviews. | Behavioural | 1, 2 |
| Traumagenic Dynamics modelThe Traumagenic Dynamics model is an influential and empirically supported model of the effects of childhood sexual abuse. The model suggests that childhood sexual abuse leads to traumatic sexualization, stigmatization, betrayal, and powerlessness and that these four traumagenic dynamics lead to adverse outcomes, including increased rates of sexual risk behavior. This model will be used to guide research interviews. | Behavioural | 1, 2 |
Primary outcome
Number of sexual partners
Time frame: Measured at Month 3
2 secondary outcomes
Frequency of unprotected intercourse
Time frame: Measured at Month 3
Proportion of episodes of unprotected intercourse
Time frame: Measured at Month 3
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 15 Apr 2013.
Related trials for HIV Infections
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.
Theresa E. Senn, PhD principal investigator
Syracuse University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections and Child Abuse, Sexual, run by Syracuse 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 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 15 Apr 2013. 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?
Number of sexual partners (time frame: Measured at Month 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Apr 2013.