Community-based Interventions to Increase HIV Testing and HIV Care Utilization
| Status: | Completed |
|---|---|
| Conditions: | HIV / AIDS |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 8/2/2018 |
| Start Date: | June 2013 |
| End Date: | December 2017 |
The purpose of this study is to conduct a cross-site evaluation of the Kaiser Permanente's
Community-based Interventions to Increase HIV Testing and HIV Care Utilization Program,
designed to support community-based interventions to reduce the number of new HIV cases and
to increase HIV care acquisition and maintenance in minority communities disproportionately
affected by the HIV epidemic. This effort builds on the President's National Strategy for HIV
Prevention and recent research documenting the importance and efficacy of "test and treat"
and "treatment as prevention" approaches. Hence, goals of this important and novel work will
focus on the following objectives:
1. identification of HIV infection among recently infected adolescents and adults
2. improved access to HIV care, particularly among newly diagnosed adolescents and adults
To achieve these objectives, the following outcomes are expected from grantee programs:
1. increased HIV testing among populations at risk for HIV
2. improved health care utilization among HIV infected adults and adolescents
This initiative has been undertaken by Kaiser to affect HIV at a population level via
community approaches to prevention, intervention and care in minority communities most
affected by HIV (e.g. gay, African American, and Latino communities). The University of
California, San Diego has developed and will oversee a cross-site evaluation of Kaiser
grantee programs funded under this initiative. Each site will have a treatment and comparison
group, and will conduct follow up surveys with their participants three and six months after
their interventions.
Community-based Interventions to Increase HIV Testing and HIV Care Utilization Program,
designed to support community-based interventions to reduce the number of new HIV cases and
to increase HIV care acquisition and maintenance in minority communities disproportionately
affected by the HIV epidemic. This effort builds on the President's National Strategy for HIV
Prevention and recent research documenting the importance and efficacy of "test and treat"
and "treatment as prevention" approaches. Hence, goals of this important and novel work will
focus on the following objectives:
1. identification of HIV infection among recently infected adolescents and adults
2. improved access to HIV care, particularly among newly diagnosed adolescents and adults
To achieve these objectives, the following outcomes are expected from grantee programs:
1. increased HIV testing among populations at risk for HIV
2. improved health care utilization among HIV infected adults and adolescents
This initiative has been undertaken by Kaiser to affect HIV at a population level via
community approaches to prevention, intervention and care in minority communities most
affected by HIV (e.g. gay, African American, and Latino communities). The University of
California, San Diego has developed and will oversee a cross-site evaluation of Kaiser
grantee programs funded under this initiative. Each site will have a treatment and comparison
group, and will conduct follow up surveys with their participants three and six months after
their interventions.
This study is a cross-site evaluation of four projects in four states which all have
two-armed study designs (intervention and comparison groups), whether quasi-experimental or
Randomly controlled trials (RCTs) (depending on site preference). Therefore, some
participants will be randomly sampled and others convenience sampled depending on the site.
Uniform surveys are approved by each sites' local Institutional Review Boards (IRBs). Trained
site staff (not involved in the interventions) will administer the interview-led surveys to
the participants, using computerized surveys for real-time data analysis and extra data
security. Surveys will last approximately one hour, and will be administered in a private
location in each site city (e.g. at the site agency) where confidentiality will be respected
and where no one else can hear the interview. Survey measures include: Demographics; General
health; Access and barriers to care; Health literacy; Non-partner related physical and sexual
abuse history; Drug and alcohol use; HIV care and utilization and other utilization; HIV risk
behaviors; HIV risk perceptions and condom attitudes; HIV stigma; Sexually transmitted
infections and HCV2; Incarceration; Involvement with police; Social support; Intimate partner
violence; Mental health; Impulsivity; Neighborhood violence and gang activity; Experiences of
Racism; Sex and gender roles. The surveys will be administered at baseline, 3 months, and 6
months follow up.
Participants working illegally or conducting illegal practices such as illicit sex or working
in establishments with illegal practices are not excluded from the study and will not be
reported to the authorities by the researchers. If ethical issues should arise, such as
danger to self or others, referrals will be made back to the site agencies and professional
social work staff for appropriate intervention.
Each site will track participation and retention rates. In addition, site staff will do their
own process evaluation, which will include the following: 1) Documenting recruitment and
follow-up of participants (participation and retention rate data), 2) Documenting program
delivery (program attendance data), 3) Monitoring high quality program delivery (program
observations- quarterly reports; oversight/supervision of program quarterly reports), 4)
Identifying impediments to high quality program delivery, planning to reduce or eliminate
impediments (program coordinator notes- quarterly reports), 5) Assessing response to program
from participants, staff, agencies (survey data; site level interview data may be useful as
well). The local IRBs will review and approve the full procedure, including the intervention
and evaluation plan at that site. The local staff will be hired by some sites after they are
funded. They will do local training on the evaluation protocol and ethical conduct of
research, as well as guidance by our UCSD evaluation staff.
Participants will vary by study site and no subjects will be enrolled in UCSD. The first
cohort includes the following sites:
1. John Wesley Community Health (JWCH) Institute, Los Angeles, California. will recruit
Black and Latino Men who have sex with Men, ages 18 and above from 3 bathhouses in
downtown Los Angeles and near Long Beach. Of 4,000 who are tested, 140 are expected to
be HIV-positive. These 140 will be randomly assigned to an Intervention group and
control group. The program's outreach team will visit these venues in person to recruit
participants and link them to an existing network of providers in the area.
2. Public Health Institute, Oakland, California. Total of 224 clients (Transgender Women of
Color), will be served by Health Educators (HE) in Alameda and San Francisco Counties.
54 HIV+ enrolled (30 newly diagnosed, 24 known HIV cases); 170 HIV negatives. Outreach
will be conducted through community outreach, online outreach via project website and
social network sites, and networks of existing service providers.
3. Fortune Society, New York: 70 People Living with HIV/AIDS (PLWHA) about to be released
from jail, plus 120 high-risk, formerly incarcerated individuals will be enrolled.
Individuals are male and female, with the majority being African American and Latino.
PLWHA will be reached by outreach staff during incarceration (detainees and inmates) in
Rikers Island facilities and post-discharge; Fortune continues working with clients
during discharge and upon their release into the community and 6 months post-discharge
via Fortune's main service center in Queens, NY.
4. Institute for Public Health Innovation, Prince George's County, Maryland. 105 PLWA
(HIV-positive African Americans, males and females, ages 18 and above) will be enrolled
in a peer based, client navigation model of an Integrated HIV/AIDS Early Intervention
Services (ARTAS) Community Health Worker (CHW) Program. The Institute will advertise
services and conduct outreach to HIV-positive African Americans through clinical
partners.
A second cohort has began recruitment as well:
5. Action. Skills. Knowledge. 4 Care. (ASK 4Care), North Carolina. Duke University. A peer
driven retention in care program that promotes HIV knowledge, communication skills,
community building, and health prioritization among people living with HIV that have
been newly diagnosed, as well as among those who are accessing care but not optimizing
it. African Americans with low socioeconomic status are the target population. This
program assists those newly diagnosed with HIV to access medical care and supportive
peer programs with the intention of promoting lifelong adherence skills. ASK 4 Care
includes eight modules that help individuals become more active in their own health
care.
6. North Jersey Community Research Initiative (NJCRI), New Jersey. NJCRI's program consists
of innovative and targeted outreach and engagement, and retention in care, as well as
focus on expanding its referral network, evaluation, and dissemination of project
findings. Injecting drug users and especially men who have sex with men (MSM) are the
target population. The program consists of three components. First, NJCRI does targeted
outreach and HIV testing. Second, NJCRI alters the linkage to care by providing
HIV-positive clients with immediate entry into care. Third, NJCRI alters the utilization
of and retention in care by providing ongoing intensive case management.
7. 2nd CHANCE (Creating a Healthy And Nurturing Community Environment), California. WORLD.
2nd Chance implements a new, peer-based model that aims to significantly expand the
number of low-income, HIV-infected women of color in Alameda County that are effectively
engaged in HIV care and adherent to HIV medications. WORLD conducts street and community
outreach to identify, link, and help low-income, HIV-infected women of color that are
not currently in the HIV care system or receiving HIV primary care or medications, to
access and retain care.
The purpose of the research will be discussed upfront with the subjects, in addition to
revealing the sponsors of the research and how data will be reported. There will be no
deception used in the survey. The consent forms will also explain the voluntary nature of the
survey, the participant's right to withdraw from the interview at any time, and to opt out of
questions they are not comfortable answering. The confidential nature of the data and
identifying information as well as the limits to confidentiality (harm to self or another)
will be explained as part of the consent process. Availability of the researcher to answer
questions concerning the study at any time will be explained. Written informed consent will
be waived, upon approval of this IRB, due to the sensitive nature of asking questions related
to HIV testing and status. Verbal informed consent will be obtained instead and a copy of the
consent form given to each participant. Participants will be given the option to reject or
withdraw their participation in this survey research at any time. If they should not elect to
participate in the protocol, alternatives available include referral to standard care
services (such as regular workshops provided) and other community=based agencies.
There are minimal potential risks associated with participation in this study. However,
participants may have an emotional reaction to discussing HIV-related issues and issues of a
personal nature. If participation in this study makes a participant feel uncomfortable or if
participants disclose information that requires further assistance by the law (child or elder
abuse, or intent to harm oneself or another person), a psychologist or social work or medical
professional may be contacted to meet with them to discuss their feelings and to determine if
any assistance is necessary. If so, a list of potential referrals will be provided and a
researcher will be in touch with them until assistance is found. Sites will vary in terms of
whether cash or non-monetary incentives are given. Also, referrals to services/ resource
lists and HIV prevention materials (e.g. condoms) will be provided by most sites.
The data safety monitoring plan for this study includes: 1) Data is transported to UCSD via a
password-protected system 2) Only sites will have ID-identified data; the data we receive at
UCSD would be completely de-identified. 3) Data submitted will only be submitted with
de-identified data that is linked with identified data and contact information. 4) Sites will
be asked to maintain notes for reasons of discontinuation in the study/program. They will be
trained to review, and ultimately determine if there are patterns for heightened risk for
study/program participants. 5) If for any reason we find adverse events as a result of the
research studies (which we will check via quarterly progress reports), we will complete an
adverse event form and immediately notify IRB and our funders. Computerized data files will
only have unique identifying numbers (i.e. 10 digit id number), and names of participants
will not be removed from the community study sites. Should participants wish to withdraw from
the study, they can choose to have the data from both baseline and follow-up surveys removed
from the study records and destroyed. Therapeutic treatment may be provided including
referral to the community-based agency, social worker, or clinic/hospitals, as needed.
This study does not involve any investigational drugs or devices. The benefits outweigh the
risks because this research only gathers survey data on behavioral outcomes. Also, interviews
of participants in both intervention and comparison groups will help service providers
monitor the needs of the target population more closely in case they need services or are
experiencing barriers. The research can provide a feedback loop back to services if
participants request them.
two-armed study designs (intervention and comparison groups), whether quasi-experimental or
Randomly controlled trials (RCTs) (depending on site preference). Therefore, some
participants will be randomly sampled and others convenience sampled depending on the site.
Uniform surveys are approved by each sites' local Institutional Review Boards (IRBs). Trained
site staff (not involved in the interventions) will administer the interview-led surveys to
the participants, using computerized surveys for real-time data analysis and extra data
security. Surveys will last approximately one hour, and will be administered in a private
location in each site city (e.g. at the site agency) where confidentiality will be respected
and where no one else can hear the interview. Survey measures include: Demographics; General
health; Access and barriers to care; Health literacy; Non-partner related physical and sexual
abuse history; Drug and alcohol use; HIV care and utilization and other utilization; HIV risk
behaviors; HIV risk perceptions and condom attitudes; HIV stigma; Sexually transmitted
infections and HCV2; Incarceration; Involvement with police; Social support; Intimate partner
violence; Mental health; Impulsivity; Neighborhood violence and gang activity; Experiences of
Racism; Sex and gender roles. The surveys will be administered at baseline, 3 months, and 6
months follow up.
Participants working illegally or conducting illegal practices such as illicit sex or working
in establishments with illegal practices are not excluded from the study and will not be
reported to the authorities by the researchers. If ethical issues should arise, such as
danger to self or others, referrals will be made back to the site agencies and professional
social work staff for appropriate intervention.
Each site will track participation and retention rates. In addition, site staff will do their
own process evaluation, which will include the following: 1) Documenting recruitment and
follow-up of participants (participation and retention rate data), 2) Documenting program
delivery (program attendance data), 3) Monitoring high quality program delivery (program
observations- quarterly reports; oversight/supervision of program quarterly reports), 4)
Identifying impediments to high quality program delivery, planning to reduce or eliminate
impediments (program coordinator notes- quarterly reports), 5) Assessing response to program
from participants, staff, agencies (survey data; site level interview data may be useful as
well). The local IRBs will review and approve the full procedure, including the intervention
and evaluation plan at that site. The local staff will be hired by some sites after they are
funded. They will do local training on the evaluation protocol and ethical conduct of
research, as well as guidance by our UCSD evaluation staff.
Participants will vary by study site and no subjects will be enrolled in UCSD. The first
cohort includes the following sites:
1. John Wesley Community Health (JWCH) Institute, Los Angeles, California. will recruit
Black and Latino Men who have sex with Men, ages 18 and above from 3 bathhouses in
downtown Los Angeles and near Long Beach. Of 4,000 who are tested, 140 are expected to
be HIV-positive. These 140 will be randomly assigned to an Intervention group and
control group. The program's outreach team will visit these venues in person to recruit
participants and link them to an existing network of providers in the area.
2. Public Health Institute, Oakland, California. Total of 224 clients (Transgender Women of
Color), will be served by Health Educators (HE) in Alameda and San Francisco Counties.
54 HIV+ enrolled (30 newly diagnosed, 24 known HIV cases); 170 HIV negatives. Outreach
will be conducted through community outreach, online outreach via project website and
social network sites, and networks of existing service providers.
3. Fortune Society, New York: 70 People Living with HIV/AIDS (PLWHA) about to be released
from jail, plus 120 high-risk, formerly incarcerated individuals will be enrolled.
Individuals are male and female, with the majority being African American and Latino.
PLWHA will be reached by outreach staff during incarceration (detainees and inmates) in
Rikers Island facilities and post-discharge; Fortune continues working with clients
during discharge and upon their release into the community and 6 months post-discharge
via Fortune's main service center in Queens, NY.
4. Institute for Public Health Innovation, Prince George's County, Maryland. 105 PLWA
(HIV-positive African Americans, males and females, ages 18 and above) will be enrolled
in a peer based, client navigation model of an Integrated HIV/AIDS Early Intervention
Services (ARTAS) Community Health Worker (CHW) Program. The Institute will advertise
services and conduct outreach to HIV-positive African Americans through clinical
partners.
A second cohort has began recruitment as well:
5. Action. Skills. Knowledge. 4 Care. (ASK 4Care), North Carolina. Duke University. A peer
driven retention in care program that promotes HIV knowledge, communication skills,
community building, and health prioritization among people living with HIV that have
been newly diagnosed, as well as among those who are accessing care but not optimizing
it. African Americans with low socioeconomic status are the target population. This
program assists those newly diagnosed with HIV to access medical care and supportive
peer programs with the intention of promoting lifelong adherence skills. ASK 4 Care
includes eight modules that help individuals become more active in their own health
care.
6. North Jersey Community Research Initiative (NJCRI), New Jersey. NJCRI's program consists
of innovative and targeted outreach and engagement, and retention in care, as well as
focus on expanding its referral network, evaluation, and dissemination of project
findings. Injecting drug users and especially men who have sex with men (MSM) are the
target population. The program consists of three components. First, NJCRI does targeted
outreach and HIV testing. Second, NJCRI alters the linkage to care by providing
HIV-positive clients with immediate entry into care. Third, NJCRI alters the utilization
of and retention in care by providing ongoing intensive case management.
7. 2nd CHANCE (Creating a Healthy And Nurturing Community Environment), California. WORLD.
2nd Chance implements a new, peer-based model that aims to significantly expand the
number of low-income, HIV-infected women of color in Alameda County that are effectively
engaged in HIV care and adherent to HIV medications. WORLD conducts street and community
outreach to identify, link, and help low-income, HIV-infected women of color that are
not currently in the HIV care system or receiving HIV primary care or medications, to
access and retain care.
The purpose of the research will be discussed upfront with the subjects, in addition to
revealing the sponsors of the research and how data will be reported. There will be no
deception used in the survey. The consent forms will also explain the voluntary nature of the
survey, the participant's right to withdraw from the interview at any time, and to opt out of
questions they are not comfortable answering. The confidential nature of the data and
identifying information as well as the limits to confidentiality (harm to self or another)
will be explained as part of the consent process. Availability of the researcher to answer
questions concerning the study at any time will be explained. Written informed consent will
be waived, upon approval of this IRB, due to the sensitive nature of asking questions related
to HIV testing and status. Verbal informed consent will be obtained instead and a copy of the
consent form given to each participant. Participants will be given the option to reject or
withdraw their participation in this survey research at any time. If they should not elect to
participate in the protocol, alternatives available include referral to standard care
services (such as regular workshops provided) and other community=based agencies.
There are minimal potential risks associated with participation in this study. However,
participants may have an emotional reaction to discussing HIV-related issues and issues of a
personal nature. If participation in this study makes a participant feel uncomfortable or if
participants disclose information that requires further assistance by the law (child or elder
abuse, or intent to harm oneself or another person), a psychologist or social work or medical
professional may be contacted to meet with them to discuss their feelings and to determine if
any assistance is necessary. If so, a list of potential referrals will be provided and a
researcher will be in touch with them until assistance is found. Sites will vary in terms of
whether cash or non-monetary incentives are given. Also, referrals to services/ resource
lists and HIV prevention materials (e.g. condoms) will be provided by most sites.
The data safety monitoring plan for this study includes: 1) Data is transported to UCSD via a
password-protected system 2) Only sites will have ID-identified data; the data we receive at
UCSD would be completely de-identified. 3) Data submitted will only be submitted with
de-identified data that is linked with identified data and contact information. 4) Sites will
be asked to maintain notes for reasons of discontinuation in the study/program. They will be
trained to review, and ultimately determine if there are patterns for heightened risk for
study/program participants. 5) If for any reason we find adverse events as a result of the
research studies (which we will check via quarterly progress reports), we will complete an
adverse event form and immediately notify IRB and our funders. Computerized data files will
only have unique identifying numbers (i.e. 10 digit id number), and names of participants
will not be removed from the community study sites. Should participants wish to withdraw from
the study, they can choose to have the data from both baseline and follow-up surveys removed
from the study records and destroyed. Therapeutic treatment may be provided including
referral to the community-based agency, social worker, or clinic/hospitals, as needed.
This study does not involve any investigational drugs or devices. The benefits outweigh the
risks because this research only gathers survey data on behavioral outcomes. Also, interviews
of participants in both intervention and comparison groups will help service providers
monitor the needs of the target population more closely in case they need services or are
experiencing barriers. The research can provide a feedback loop back to services if
participants request them.
Inclusion Criteria:
- Individuals will be adults,
- aged 18 and over,
- with the capacity to give informed consent.
Exclusion Criteria:
Those who do not have the capacity to give informed consent will be excluded.
We found this trial at
1
site
La Jolla, California 92093
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