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HIV RiskPhase 1NCT01866046

Rapid HIV Testing and Counseling in High Risk Women in Shelters

A Phase 1 study testing RESPECT-IPV in people with HIV Risk, run by The University of Akron at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a developmental study evaluating a new rapid HIV testing and risk prevention intervention for residents of battered women's shelters who endorse risky sexual behaviors. Read more about this study

Who is it for?
Any age, women only
Conditions the study is for
HIV Risk
What is being tested?
RESPECT-IPV
Could I receive a placebo?
No, everyone receives an active treatment
How many people
98 participants
Where
1 siteUnited States
Study dates
Jan 2013to Mar 2015
Phase
Phase 1
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 Any age
  • Women only
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • intimate partner violence and at least one unprotected sexual occasion 3 months prior to entering shelter

Who cannot join

  • HIV positive

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Akron

    Akron, Ohio, 44325

Other trials in United States

About this study

This is a developmental study evaluating a new rapid HIV testing and risk prevention intervention for residents of battered women's shelters who endorse risky sexual behaviors.

Read the detailed description
  1. Specific Aims More than one million Americans are living with HIV, with over 20% unaware of their HIV status. Early detection of HIV status is crucial to prevent transmission to others and to link those who are HIV positive to medical care and other clinical services. Consistently, the National HIV/AIDS strategy has established a goal of increasing the awareness of HIV status in Americans from 79% to 90% within the next four years. Thus, there is a strong need for increased testing efforts, particularly among high risk, underserved populations. To be effective, these testing efforts need to address many of the barriers to testing and linkage to care faced by these underserved populations. Victims of intimate partner violence (IPV) are one such underserved population who are at high risk for HIV infection and face many barriers to testing and linkage to care.

IPV is a pervasive public health problem with 25% of women reporting IPV in their lifetime. A growing body of literature highlights the association between IPV and HIV risk. IPV victims are more likely to engage in HIV risk behaviors, including unprotected sex, sex with risky partners (e.g., HIV-positive, injection drug users), sex with more than one sex partner, and trading sex, and are more likely to have a sexually transmitted disease (STI). Additionally, posttraumatic stress disorder (PTSD) and substance use disorder (SUD), highly prevalent in IPV victims, are associated with high risk sexual behaviors. Furthermore, women with IPV underutilize medical care and often encounter numerous barriers to health care (e.g., transportation, under or un-insured). Unfortunately, very few HIV prevention interventions have been developed or tested for this vulnerable and underserved population of women.

IPV Victims in domestic shelters are at significant risk for HIV (i.e., 69-87% report unprotected sex and 33% report having an STI). Domestic violence shelters also present an opportune setting for providing health care services for women. There are approximately 2,000 community-based shelter programs throughout the US, providing emergency shelter to approximately 300,000 women and children each year. Considering the number of women who seek help from these facilities and that IPV victims who seek shelter have already instituted a change in their life, a prime time to intervene may be while these women are already seeking help from these community based organizations. Further, domestic shelters provide a safe and supportive environment which is ideal for HIV testing and prevention. Thus incorporating HIV testing and prevention within domestic shelters will provide access to a significant population of women with an overall high risk for HIV infection while significantly reducing many of the barriers to testing and linkage to care faced by IPV victims. Rapid HIV testing allows for provision of HIV testing, counseling, and test results in one visit, eliminating the problem of clients not returning for test results. Thus, rapid testing offers an ideal option for residents of domestic shelters, given their multiple competing demands and barriers to traditional HIV testing and prevention. RESPECT is an evidence-based CDC Diffusion of Effective Behavioral Interventions (DEBI), utilizing a client-focused, interactive HIV risk reduction counseling model delivered in conjunction with HIV testing. RESPECT-2, which has been adapted for use with rapid testing, is brief and easily adaptable to many clinical settings. IPV victims, however, face distinct HIV risk factors, such as difficulty in negotiating condom use and other preventative sexual behaviors, out of fear of retaliation or being raped by their abusive partner. Hence, RESPECT-2 needs to be tailored to meet the specific needs of our target population.

The Specific Aims of this R21 Exploratory/Developmental Research Proposal are to (a) expand RESPECT-2 for our target population (i.e., RESPECT-IPV) and (b) to collect preliminary data on RESPECT-IPV + rapid testing's feasibility, acceptability, and initial efficacy in residents of domestic shelters. To facilitate sustainability and future dissemination of RESPECT-IPV + rapid testing, the intervention will be delivered by trained personnel from community-based CDC supported counseling, testing, and referral (CTC) sites.

The development aim of this R21 proposal is to develop the manual for RESPECT-IPV, incorporating information gathered from four focus groups with IPV victims and two focus groups with shelter staff, the literature on IPV and HIV risk, and a pre-pilot open trial to increase acceptability of RESPECT-IPV and to tailor the intervention to meet the unique needs of our target population. The pilot study aims of this R21 proposal are to: (1) Assess the feasibility and acceptability of RESPECT-IPV + rapid testing in a sample of 100 high-risk shelter women. Predictors of acceptability (e.g., PTSD symptoms, substance use, IPV severity, prior testing history, HIV knowledge, HIV risk behavior, HIV anxiety, stage of change) will also be explored. (2) Conduct an open trial of RESPECT-IPV + rapid testing in a sample of 100 high-risk shelter women and examine preliminary evidence for the hypotheses that RESPECT-IPV will be associated with reduced unprotected vaginal or anal sex occasions (USOs) at 1-week and 3-months after leaving shelter and fewer cases of vaginal trichomoniasis 3-months after leaving shelter. Secondary outcomes include HIV knowledge, risk intentions, and other HIV risk behaviors (e.g. multiple partners, substance use). As a result we will have created a novel testing and counseling intervention for high-risk, underserved, shelter women, providing the groundwork to test RESPECT-IPV's efficacy in future R01 clinical trials and dissemination studies.

Conditions
HIV Risk
Being tested
RESPECT-IPV
Keywords
battered women, HIV risk, STI risk

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RESPECT-IPVBehavioural

    rapid HIV testing intervention and behavioral counseling session where identify risks and develop a risk reduction plan

Study groups in NCT01866046
Study groupRoleWhat they receive
RESPECT-IPVExperimentalRapid HIV testing and risk prevention intervention for victims of intimate partner violence
Receives: Behavioral: RESPECT-IPV

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. number of unprotected sexual occasions

    Calendar assessment of number of unprotected sexual occasions

    Measured: up to 3 months post shelter

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 May 2013 (estimated)
  2. Study startJan 2013
  3. Primary completionOct 2014
  4. Study completionMar 2015

Resources

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 1
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
98 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01866046
Sponsor's protocol ID
R21NR013628-02
Status last verified
Mar 2015
First submitted
28 May 2013
Last updated
26 Mar 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • Johnson DM, Johnson NL, Beckwith CG, Palmieri PA, Zlotnick C. Rapid Human Immunodeficiency Virus Testing and Risk Prevention in Residents of Battered Women's Shelters. Womens Health Issues. 2017 Jan-Feb;27(1):36-42. doi: 10.1016/j.whi.2016.10.007. Epub 2016 Nov 30.

    PubMed 27914861

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing RESPECT-IPV in people with HIV Risk, run by The University of Akron 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 26 Mar 2015. 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.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

number of unprotected sexual occasions (time frame: up to 3 months post shelter). 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 NCT01866046, 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 26 Mar 2015.

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