Unsafe SexNCT01907126
HIV/STI Risk Reduction for Incarcerated Women With Interpersonal Violence
A study testing Nutrition Program (NP) and Women's Prison CoOp (WPC) in people with Unsafe Sex and Physical Violence, run by Brown University at 3 sites in United States.
Trial summary
The pilot study aims to conduct a randomized pilot trial in a sample of 40 incarcerated women with lifetime interpersonal violence who are 6-10 weeks away from release to demonstrate the feasibility and acceptability of the proposed recruitment methods and research design, of the intervention training methods, of… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Unsafe Sex, Physical Violence, Sexual Assault
- What is being tested?
- Nutrition Program (NP) and Women's Prison CoOp (WPC)
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 3 sitesUnited States
- Study dates
- Sep 2011to Oct 2014
- 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
- Females in prison
- Experienced lifetime interpersonal violence (includes physical or sexual assault or abuse)
- At least one unprotected sexual occasion with a male partner within the 90 days prior to incarceration
- Approximately 6-10 weeks before release
- Expect to be released to locations within RI or MA
Who cannot join
- Cannot complete intake interview due to problems with reality testing, brain impairment, or language barrier
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Adult Correctional Institution
Cranston, Rhode Island, 02920
Massachusetts CorrectionalInstitution - Framingham
Framingham, Massachusetts, 01702
South Middlesex CorrectionalCenter
Framingham, Massachusetts, 01702
About this study
The pilot study aims to conduct a randomized pilot trial in a sample of 40 incarcerated women with lifetime interpersonal violence who are 6-10 weeks away from release to demonstrate the feasibility and acceptability of the proposed recruitment methods and research design, of the intervention training methods, of delivering the enhanced Women's Coop and nutrition control interventions. Per recent guidance from NIMH, the investigators will also examine 95% confidence intervals around differences between the proposed intervention and a dose-matched control condition (Nutrition Program), for the following outcomes through 8 months post prison release: reduced unprotected vaginal or anal sex occasions and fewer cases of vaginal trichomoniasis (primary); reduced interpersonal violence episodes, symptoms of PTSD and depression, and drug using/heavy drinking days (secondary); and increased affect management and social support (including effectiveness in obtaining substance use, mental health treatment and other resources) (tertiary).
- Conditions
- Unsafe Sex, Physical Violence, Sexual Assault, Sexual Abuse
- Being tested
- Nutrition Program (NP), Women's Prison CoOp (WPC)
- Keywords
- HIV, Sexually transmitted infections, Sexual abuse, Physical abuse, Women, Prison
- Medical subject headings
- Unsafe Sex, Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutrition Program (NP)Behavioural
Nutrition Program (NP) participants will receive the same number, format, and schedule of group and individual 60-minute sessions, which will focus on low-cost strategies for improving nutrition.
Women's Prison CoOp (WPC)Behavioural
Weekly as 60-minute sessions, 3 group and two individual sessions during incarceration as close to prison discharge as possible. Session 1 focuses on understanding and reviewing HIV risks, including interpersonal violence. Session 2 addresses gender, power, violence, and affect management to counter the emotional effects of violence. Session 3 addresses IV-specific sexual safety skills, including affect management skills. Session 4 helps women begin to develop a personalized safety plan, which may include increasing social support and access to resources. Session 5 helps her finalize and practice the plan, and Session 6 problem-solves any difficulties that have arisen in executing the plan.
| Study group | Role | What they receive |
|---|---|---|
| Women's Prison CoOp (WPC) | Experimental | Will receive 5 group psychoeducation sessions plus individual pre-release and post-release goal planning sessions. Psychoeducation sessions will cover HIV risk and violence prevention, interpersonal violence-specific sexual safety skills, empowerment through knowledge and treatment, and skills for increasing affect regulation and social support. Receives: Behavioral: Women's Prison CoOp (WPC) |
| Nutrition program (NP) | Placebo comparator | Participants in this condition will receive dose-matched nutrition education. Receives: Behavioral: Nutrition Program (NP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Unprotected Sexual Occasions (USOs; Vaginal and Anal)
The investigators will calculate effect sizes and confidence intervals for number of USOs. The number of USOs will be measured by the Timeline Follow Back (TLFB).
Measured: Slope over time: Baseline, 2 months after release, 5 months after release, 8 months after release
Presence of Trichomoniasis
The investigators will calculate odds ratios and 95% confidence intervals for any positive trichomoniasis test during follow-up using logistic regression, with baseline trichomoniasis status as a covariate. The presence of Trichomoniasis is measured by rapid test.
Measured: Slope over time: Baseline, 2 months after release, 5 months after release, 8 months after release
Treatment Acceptability
The investigators will assess the feasibility and acceptability of WPC and NP by examining rates of treatment attendance, rates of treatment completion (attending at least 5 of the 6 scheduled individual sessions) and drop-out, and scores on the End of Treatment Questionnaire. Additionally, they will examine reasons for termination for consistent patterns. Acceptability of both WPC and NP using data from Client Satisfaction Questionnaire and detailed exit interviews will be examined.
Measured: 2 months post release
Treatment Feasibility
One of the primary goals of a treatment development study is to demonstrate the feasibility of the proposed treatment and of the study and recruitment methods. As a result, the investigators will assess the feasibility of the research procedures by examining study recruitment and refusal rates, participants' willingness to be randomized, follow-up rates, reliability and range of responses to study questionnaires, and success of the interventionist training program
Measured: 2 months post release
Secondary outcomes (4)
Interpersonal violence (IPV) episodes
Episodes of interpersonal violence (physical or sexual abuse or assault) as measured by the Trauma History Questionnaire (THQ) and the Conflict Tactic Scale (CTS2). The investigators will calculate the effect size and 95% confidence intervals for number of interpersonal violence episodes during the follow-up period using Trauma History Q data. For women who have been in at least one romantic relationship during the follow-up period, the investigators will also explore differences in IPV severity using CTS2 scores. Exploratory tests for differences between conditions will use hierarchical linear modeling (HLM), with baseline scores as covariates.
Measured: Slope over time: Baseline, 2 months after release, 5 months after release, 8 months after release
PTSD Symptom Severity
PTSD Symptom Severity as measured by the Davidson Trauma Scale (DTS). The investigators will calculate effect sizes and 95% confidence intervals for reduction in PTSD symptoms using the DTS total scores. Exploratory tests for differences between conditions will use HLM with baseline scores as covariates.
Measured: Slope over time: Baseline, Pre-release, 2 months after release, 5 months after release, 8 months after release
Depressive Symptom Severity
Depressive Symptom Severity as measured by the Quick Inventory of Depressive Symptomatology Self Report (QIDS-SR). The investigators will calculate effect sizes and 95% confidence intervals for reduction in depressive symptoms using the QIDS-SR total scores. Exploratory tests for differences between conditions will use HLM with baseline scores as covariates.
Measured: Slope over time: Baseline, Pre-release, 2 months after release, 5 months after release, 8 months after release
Post Release Drug Using/Heavy Drinking Days
Total number of days that women used drugs or had 4+ drinks as measured by the Timeline Followback (TLFB). Self-report data will be compared to significant other report, urine drug screens, and breath alcohol tests. The investigators will calculate effect sizes and 95% confidence intervals for number of drug using/heavy drinking days using TLFB data. Exploratory tests for differences bet-ween conditions will use HLM with using/heavy drinking days in the 90 prior to incarceration as a covariate
Measured: Slope over time: 2 months after release, 5 months after release, 8 months after release
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2013 (estimated)
- Study startSep 2011
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Unsafe SexStudies of the same condition, open and under way.
- More trials run by Brown 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brown University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Dr. Jennifer Johnson, Brown University
- Investigators
- Jennifer E Johnson, PhD, Principal investigator, Brown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01907126
- Sponsor's protocol ID
- R34MH094188
- Other IDs
- R34MH094188
- Status last verified
- Mar 2025
- First submitted
- 28 May 2013
- Last updated
- 20 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kuo CC, Rosen RK, Zlotnick C, Wechsberg WM, Peabody M, Johnson JE. Sexual health prevention for incarcerated women: eroticising safe sex during re-entry to the community. BMJ Sex Reprod Health. 2018 Jun 28:bmjsrh-2017-200024. doi: 10.1136/bmjsrh-2017-200024. Online ahead of print.
PubMed 29954877
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HIV/STI Risk Reduction for Incarcerated Women With Interpersonal Violence
- ClinicalTrials.gov ID
- NCT01907126
- Acronym / sponsor ID
- R34MH094188
- Conditions
- Unsafe Sex, Physical Violence, Sexual Assault, Sexual Abuse
- Keywords
- HIV, Sexually transmitted infections, Sexual abuse, Physical abuse, Women, Prison
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Brown UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Sep 2011
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 24 Jul 2013 (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 pilot study aims to conduct a randomized pilot trial in a sample of 40 incarcerated women with lifetime interpersonal violence who are 6-10 weeks away from release to demonstrate the feasibility and acceptability of the proposed recruitment methods and research design, of the intervention training methods, of delivering the enhanced Women's Coop and nutrition control interventions. Per recent guidance from NIMH, the investigators will also examine 95% confidence intervals around differences between the proposed intervention and a dose-matched control condition (Nutrition Program), for the following outcomes through 8 months post prison release: reduced unprotected vaginal or anal sex occasions and fewer cases of vaginal trichomoniasis (primary); reduced interpersonal violence episodes, symptoms of PTSD and depression, and drug using/heavy drinking days (secondary); and increased affect management and social support (including effectiveness in obtaining substance use, mental health treatment and other resources) (tertiary).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Women's Prison CoOp (WPC) | Experimental | Behavioral: Women's Prison CoOp (WPC)Will receive 5 group psychoeducation sessions plus individual pre-release and post-release goal planning sessions. Psychoeducation sessions will cover HIV risk and violence prevention, interpersonal violence-specific sexual safety skills, empowerment through knowledge and treatment, and skills for increasing affect regulation and social support. |
| Nutrition program (NP) | Placebo comparator | Behavioral: Nutrition Program (NP)Participants in this condition will receive dose-matched nutrition education. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Females in prison
- Experienced lifetime interpersonal violence (includes physical or sexual assault or abuse)
- At least one unprotected sexual occasion with a male partner within the 90 days prior to incarceration
- Approximately 6-10 weeks before release
- Expect to be released to locations within RI or MA
Key exclusion criteria (1 listed)
- Cannot complete intake interview due to problems with reality testing, brain impairment, or language barrier
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 |
|---|---|---|
| Nutrition Program (NP)Nutrition Program (NP) participants will receive the same number, format, and schedule of group and individual 60-minute sessions, which will focus on low-cost strategies for improving nutrition. | Behavioural | Nutrition program (NP) |
| Women's Prison CoOp (WPC)Weekly as 60-minute sessions, 3 group and two individual sessions during incarceration as close to prison discharge as possible. Session 1 focuses on understanding and reviewing HIV risks, including interpersonal violence. Session 2 addresses gender, power, violence, and affect management to counter the emotional effects of violence. Session 3 addresses IV-specific sexual safety skills, including affect management skills. Session 4 helps women begin to develop a personalized safety plan, which may include increasing social support and access to resources. Session 5 helps her finalize and practice the plan, and Session 6 problem-solves any difficulties that have arisen in executing the plan. | Behavioural | Women's Prison CoOp (WPC) |
Primary outcome
Number of Unprotected Sexual Occasions (USOs; Vaginal and Anal)
Time frame: Slope over time: Baseline, 2 months after release, 5 months after release, 8 months after release
The investigators will calculate effect sizes and confidence intervals for number of USOs. The number of USOs will be measured by the Timeline Follow Back (TLFB).
Presence of Trichomoniasis
Time frame: Slope over time: Baseline, 2 months after release, 5 months after release, 8 months after release
The investigators will calculate odds ratios and 95% confidence intervals for any positive trichomoniasis test during follow-up using logistic regression, with baseline trichomoniasis status as a covariate. The presence of Trichomoniasis is measured by rapid test.
Treatment Acceptability
Time frame: 2 months post release
The investigators will assess the feasibility and acceptability of WPC and NP by examining rates of treatment attendance, rates of treatment completion (attending at least 5 of the 6 scheduled individual sessions) and drop-out, and scores on the End of Treatment Questionnaire. Additionally, they will examine reasons for termination for consistent patterns. Acceptability of both WPC and NP using data from Client Satisfaction Questionnaire and detailed exit interviews will be examined.
Treatment Feasibility
Time frame: 2 months post release
One of the primary goals of a treatment development study is to demonstrate the feasibility of the proposed treatment and of the study and recruitment methods. As a result, the investigators will assess the feasibility of the research procedures by examining study recruitment and refusal rates, participants' willingness to be randomized, follow-up rates, reliability and range of responses to study questionnaires, and success of the interventionist training program
4 secondary outcomes
Interpersonal violence (IPV) episodes
Time frame: Slope over time: Baseline, 2 months after release, 5 months after release, 8 months after release
PTSD Symptom Severity
Time frame: Slope over time: Baseline, Pre-release, 2 months after release, 5 months after release, 8 months after release
Depressive Symptom Severity
Time frame: Slope over time: Baseline, Pre-release, 2 months after release, 5 months after release, 8 months after release
Post Release Drug Using/Heavy Drinking Days
Time frame: Slope over time: 2 months after release, 5 months after release, 8 months after release
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 20 Mar 2025.
- Derived from this study: PubMed 29954877Kuo CC, Rosen RK, Zlotnick C, Wechsberg WM, Peabody M, Johnson JE. Sexual health prevention for incarcerated women: eroticising safe sex during re-entry to the community. BMJ Sex Reprod Health. 2018 Jun 28:bmjsrh-2017-200024. doi: 10.1136/bmjsrh-2017-200024. Online ahead of print.
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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.
Jennifer E Johnson, PhD principal investigator
Brown 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 Nutrition Program (NP) and Women's Prison CoOp (WPC) in people with Unsafe Sex and Physical Violence, run by Brown 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 5 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 20 Mar 2025. 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. 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.
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 Unprotected Sexual Occasions (USOs; Vaginal and Anal) (time frame: Slope over time: Baseline, 2 months after release, 5 months after release, 8 months after release). The study lists 4 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 NCT01907126, which also lists 1 linked publication.
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 20 Mar 2025.