Community-based Interventions to Increase HIV Testing and HIV Care Utilization
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|ClinicalTrials.gov Identifier: NCT01867177|
Recruitment Status : Recruiting
First Posted : June 3, 2013
Last Update Posted : September 22, 2016
|First Submitted Date ICMJE||May 29, 2013|
|First Posted Date ICMJE||June 3, 2013|
|Last Update Posted Date||September 22, 2016|
|Start Date ICMJE||June 2013|
|Estimated Primary Completion Date||December 2016 (Final data collection date for primary outcome measure)|
|Current Primary Outcome Measures ICMJE
||Increased HIV care utilization [ Time Frame: 3 and 6 months following intervention ]
Improved access to HIV care, particularly among newly diagnosed adults.
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||Complete list of historical versions of study NCT01867177 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
||Increased HIV testing among populations at risk for HIV [ Time Frame: at baseline ]
Increased HIV testing among populations at risk for HIV and identification of HIV infection among recently infected adults.
|Original Secondary Outcome Measures ICMJE||Same as current|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Community-based Interventions to Increase HIV Testing and HIV Care Utilization|
|Official Title ICMJE||Community-based Interventions to Increase HIV Testing and HIV Care Utilization|
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:
To achieve these objectives, the following outcomes are expected from grantee programs:
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:
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.
|Study Type ICMJE||Interventional|
|Study Phase||Not Provided|
|Study Design ICMJE||Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Recruiting|
|Estimated Enrollment ICMJE||800|
|Estimated Completion Date||December 2016|
|Estimated Primary Completion Date||December 2016 (Final data collection date for primary outcome measure)|
|Eligibility Criteria ICMJE||
Those who do not have the capacity to give informed consent will be excluded.
|Ages||18 Years and older (Adult, Senior)|
|Accepts Healthy Volunteers||Yes|
|Listed Location Countries ICMJE||United States|
|Removed Location Countries|
|NCT Number ICMJE||NCT01867177|
|Other Study ID Numbers ICMJE||KP2012|
|Has Data Monitoring Committee||Yes|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||Kaiser Permanente|
|Study Sponsor ICMJE||Kaiser Permanente|
|Collaborators ICMJE||University of California, San Diego|
|PRS Account||Kaiser Permanente|
|Verification Date||September 2016|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP