Sexual BehaviorNCT02118948
Development of a Novel HIV Risk Reduction Intervention for Abused Women
A study testing Abuse-focused intervention and Sexual behavior-focused intervention in people with Sexual Behavior, run by The Miriam Hospital at 1 site in United States.
Trial summary
The purpose of this study is to develop and evaluate an HIV risk reduction intervention for women with a history of abuse. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Sexual Behavior
- What is being tested?
- Abuse-focused intervention and Sexual behavior-focused intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to Jul 2016
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- history of abuse
- current sexual risk behavior
Who cannot join
- less than age 18
- impaired mentally
- do not speak English
- severely depressed or suicidal
- HIV+
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to develop and evaluate an HIV risk reduction intervention for women with a history of abuse.
Read the detailed description
The purpose of the proposed research is to pilot test an innovative, theoretically-guided sexual risk reduction intervention for women with a history of abuse. T intervention builds on previous findings suggesting that it is important to address the psychological consequences of abuse, as well as the typical antecedents of sexual risk behavior. To inform intervention development, women who reported a history of abuse were recruited to participate in key informant interviews. Based on interview findings and guided by theory and empirical precedent, a novel sexual risk reduction intervention was developed and refined. The intervention will be pilot tested with 80 women recruited from a publicly-funded clinic who report a history of abuse and current sexual risk behavior. These women will complete a computerized survey to assess abuse, adult sexual risk behavior, HIV-related information, safer sex motivation, behavioral skills, interpersonal trust, guilt, and powerlessness. Behavioral skills will also be assessed through role-plays and simulation scenarios. Women will be randomly assigned to the novel intervention or to a structurally equivalent intervention focused only on the psychological antecedents of sexual risk behavior. Three months after intervention completion, women will return to complete computerized interviews and behavioral skills assessments. The long-term goal of this research is to develop a feasible and effective sexual risk reduction intervention for women who have a history of abuse.
- Conditions
- Sexual Behavior
- Being tested
- Abuse-focused intervention, Sexual behavior-focused intervention
- Keywords
- abuse, sexual behavior, sexual risk reduction, behavioral intervention
- Medical subject headings
- Sexual Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abuse-focused interventionBehavioural
Sexual behavior-focused interventionBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Abuse-focused intervention | Experimental | Participants attend 5 weekly, 2-hour intervention sessions focused on the psychological consequences of abuse, current sexual risk behavior, and the link between the two. Receives: Behavioral: Abuse-focused intervention |
| Sexual behavior-focused intervention | Active comparator | Participants attend 5 weekly, 2-hour intervention sessions focused on current sexual risk behavior. Receives: Behavioral: Sexual behavior-focused intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in number of sexual partners in the past 3 months
at baseline and at 3 months post intervention, participants will respond to the question, "How many sexual partners have you had in the past 3 months?", assessed by computerized survey
Measured: baseline and 3 months
change in number of episodes of unprotected sex in the past 3 months
at baseline and at 3 months post intervention, participants will report (a) the number of times they had sex with a primary partner in the past 3 months (b) out of the number of sex episodes with a primary partner in the past 3 months, how many times a condom was used; (c) the number of times they had sex with non-primary partners in the past 3 months; and (d) out of the number of sex episodes with a non-primary partner in the past 3 months, how many times a condom was used; responses to these 4 items will be used to determine the change in the total number of unprotected sex episodes (past 3 months) from baseline to 3 months post-intervention, assessed by computerized survey
Measured: baseline and 3 months
Secondary outcomes (8)
change in scores on the HIV Knowledge Questionnaire
assessed by computerized survey
Measured: baseline and 3 months
change in scores on Condom Attitudes measure
condom attitudes measure assessing (a) attitudes towards condom use in primary relationships; (b) attitudes towards condom use in non-primary relationship; (c) pleasure-related condom attitudes; and (d) respect-related condom attitudes, assessed by computerized survey
Measured: baseline and 3 months
change in performance on condom application exercise
participant is observed and scored while placing a condom on a model
Measured: baseline and 3 months
change in scores on Traumatic Sexualization Survey
assessed by computerized survey
Measured: baseline and 3 months
change in scores on Dyadic Trust Scale
assessed by computerized survey
Measured: baseline and 3 months
change in scores on Abuse-Related Beliefs Questionnaire
assessed by computerized survey
Measured: baseline and 3 months
change in scores on Sexual Relationship Power Scale
assessed by computerized survey
Measured: baseline and 3 months
change in scoress on the PTSD Checklist-Civilian Version
assessed via computerized survey at baseline and via paper and pencil survey at the end of each intervention session
Measured: baseline and after each intervention session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sexual BehaviorStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Miriam Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Rochester
- Responsible party
- Principal investigator, Theresa E. Senn, The Miriam Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02118948
- Sponsor's protocol ID
- R34MH095362
- Status last verified
- Aug 2016
- First submitted
- 14 Apr 2014
- Last updated
- 29 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Novel HIV Risk Reduction Intervention for Abused Women
- ClinicalTrials.gov ID
- NCT02118948
- Acronym / sponsor ID
- R34MH095362
- Conditions
- Sexual Behavior
- Keywords
- abuse, sexual behavior, sexual risk reduction, behavioral intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- The Miriam HospitalUniversity, hospital or other
- Collaborators
- University of Rochester
- Study start
- Apr 2014
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 21 Apr 2014 (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 purpose of this study is to develop and evaluate an HIV risk reduction intervention for women with a history of abuse.
Detailed description
The purpose of the proposed research is to pilot test an innovative, theoretically-guided sexual risk reduction intervention for women with a history of abuse. T intervention builds on previous findings suggesting that it is important to address the psychological consequences of abuse, as well as the typical antecedents of sexual risk behavior. To inform intervention development, women who reported a history of abuse were recruited to participate in key informant interviews. Based on interview findings and guided by theory and empirical precedent, a novel sexual risk reduction intervention was developed and refined. The intervention will be pilot tested with 80 women recruited from a publicly-funded clinic who report a history of abuse and current sexual risk behavior. These women will complete a computerized survey to assess abuse, adult sexual risk behavior, HIV-related information, safer sex motivation, behavioral skills, interpersonal trust, guilt, and powerlessness. Behavioral skills will also be assessed through role-plays and simulation scenarios. Women will be randomly assigned to the novel intervention or to a structurally equivalent intervention focused only on the psychological antecedents of sexual risk behavior. Three months after intervention completion, women will return to complete computerized interviews and behavioral skills assessments. The long-term goal of this research is to develop a feasible and effective sexual risk reduction intervention for women who have a history of abuse.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Abuse-focused intervention | Experimental | Behavioral: Abuse-focused interventionParticipants attend 5 weekly, 2-hour intervention sessions focused on the psychological consequences of abuse, current sexual risk behavior, and the link between the two. |
| Sexual behavior-focused intervention | Active comparator | Behavioral: Sexual behavior-focused interventionParticipants attend 5 weekly, 2-hour intervention sessions focused on current sexual risk behavior. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- history of abuse
- current sexual risk behavior
Key exclusion criteria (5 listed)
- less than age 18
- impaired mentally
- do not speak English
- severely depressed or suicidal
- HIV+
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 |
|---|---|---|
| Abuse-focused intervention | Behavioural | Abuse-focused intervention |
| Sexual behavior-focused intervention | Behavioural | Sexual behavior-focused intervention |
Primary outcome
change in number of sexual partners in the past 3 months
Time frame: baseline and 3 months
at baseline and at 3 months post intervention, participants will respond to the question, "How many sexual partners have you had in the past 3 months?", assessed by computerized survey
change in number of episodes of unprotected sex in the past 3 months
Time frame: baseline and 3 months
at baseline and at 3 months post intervention, participants will report (a) the number of times they had sex with a primary partner in the past 3 months (b) out of the number of sex episodes with a primary partner in the past 3 months, how many times a condom was used; (c) the number of times they had sex with non-primary partners in the past 3 months; and (d) out of the number of sex episodes with a non-primary partner in the past 3 months, how many times a condom was used; responses to these 4 items will be used to determine the change in the total number of unprotected sex episodes (past 3 months) from baseline to 3 months post-intervention, assessed by computerized survey
8 secondary outcomes
change in scores on the HIV Knowledge Questionnaire
Time frame: baseline and 3 months
change in scores on Condom Attitudes measure
Time frame: baseline and 3 months
change in performance on condom application exercise
Time frame: baseline and 3 months
change in scores on Traumatic Sexualization Survey
Time frame: baseline and 3 months
change in scores on Dyadic Trust Scale
Time frame: baseline and 3 months
change in scores on Abuse-Related Beliefs Questionnaire
Time frame: baseline and 3 months
change in scores on Sexual Relationship Power Scale
Time frame: baseline and 3 months
change in scoress on the PTSD Checklist-Civilian Version
Time frame: baseline and after each intervention session
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 29 Aug 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Abuse-focused intervention and Sexual behavior-focused intervention in people with Sexual Behavior, run by The Miriam Hospital 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 2 inclusion and 5 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 29 Aug 2016. 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?
change in number of sexual partners in the past 3 months (time frame: baseline and 3 months). The study lists 2 primary outcomes in all. 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 29 Aug 2016.