Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT01866046 |
| Other study ID # |
R21NR013628-02 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Phase 1
|
| First received |
May 28, 2013 |
| Last updated |
March 24, 2015 |
| Start date |
January 2013 |
| Est. completion date |
March 2015 |
Study information
| Verified date |
March 2015 |
| Source |
The University of Akron |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
United States: NIH |
| Study type |
Interventional
|
Clinical 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.
Description:
A. 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.
