Prevention with Positives Pre-Solicitation Notice.pdf

Project Title:

“Implementation and Evaluation of a Comprehensive Prevention with HIV Positives (PwP) Patients Intervention at HIV Clinics”

Pre-Solicitation Notice for Solicitation 2011-N-13271

1. Introduction. This is a Pre-solicitation Notice for a Full and Open Competition under North American Industry Classification System (NAICS) code 541720 “Research and Development in the Social Sciences and Humanities”, with a small business size standard of $7 Million. When released the solicitation number will be 2011-N-13271.

The solicitation Request for Proposal (RFP) will be made available on the Internet at http://www.fbo.gov on or about 28 March 2011. Request for Proposals will not be provided to interested parties in hard copy form.

Telephone requests will not be honored. Interested parties are responsible for checking the website regularly for the release of the RFP and for other procurement-related documents. The information provided in this pre-solicitation is for information purposes only. If there are any differences in the information provided here and the actual solicitation, the information provided in the actual solicitation shall govern.

2. Overview: The Centers for Disease Control and Prevention (CDC), National Center for HIV/AIDS, Viral Hepatitis, STD and TB Prevention (NCHHSTP), Division of HIV/AIDS Prevention (DHAP), Epidemiology Branch (EB), is contemplating multiple awards for this project.

Purpose: To improve HIV patients’ health and reduce transmission of HIV infection, there is a need for a comprehensive Prevention-with-Positives (PwP) intervention that gives attention to sexual and drug risk behaviors, retention in care, adherence to treatment regimen, and provision of ART at earlier stages of disease.

Objectives:

a) To obtain a plan for integrating a comprehensive HIV prevention intervention into an HIV clinic;

b) To obtain a study operations manual, local IRB approval, and results of pilot testing;

c) Implement and oversee the HIV prevention intervention at the HIV clinic, collect data that will be used to evaluate the intervention, conduct quality control activities, and transmit the data to

CDC.

d) Conduct a survey/interview study involving a sample of patients and their primary sex partners (dyads) to examine behavioral, attitudinal, and interpersonal variables that may influence prevention activities within primary relationships

Minimum Patient Sample Size and the Clinic Site’s Minimum Qualification: The contractor’s selected HIV clinic must currently serve at least 900 unduplicated HIV+ patients who have attended the clinic for HIV primary medical care in the most current 12-month period. The minimum acceptable count of 900 unduplicated HIV+ primary care patients must all be served by a single, physical clinic location (satellite and part-time remote clinics must not be included in the count).

Anticipate six contract awards: Contractors are expected to have a working relationship with one (1) clinic that meets the patient sample size standards stated above. Six contractors may be required to appropriately study the impact of intervention efforts.

http://www.fbo.gov/

3. Background for the Acquisition. Approximately half of all new HIV infections in the United States stem from sexual risk behaviors of HIV-positive persons who are aware of their seropositive status.1 Approximately two-thirds of these HIV+/aware persons enter medical care within a year of being diagnosed.2 The HIV medical care setting is thus an ideal location for delivering a sustainable behavioral intervention to large numbers of HIV-positive persons, with the goal of improving patients’ health and reducing the potential for transmission of HIV infection. To reach this goal, a comprehensive intervention is needed that not only addresses sexual and drug risk behaviors directly, but also attempts to improve patients’ retention in medical care and their adherence to treatment regimens.

Observational studies indicate that approximately 40-50% of HIV+/aware persons who have been seen by HIV medical providers are not stable in care (i.e., they miss scheduled appointments or have large gaps between care visits).3,4 Patients who “feel well” or are not on antiretroviral therapy (ART) may exhibit a higher level of inconsistent attendance for medical care compared with their counterparts.5 Other studies have shown that for every 100 cells/mm3 increase in CD4 count, there was a 20% increase in the probability of discontinuing primary

HIV care within the first 6 months of care entry.6

Improving the regularity with which HIV patients attend clinic may facilitate adherence to ART which may lead to medical and prevention benefits. Patients on ART who saw their medical providers regularly were more likely to have suppressed viral load than those who saw their providers’ irregularly.7 Importantly, those with suppressed viral load are less infectious and thus less likely to transmit HIV infection through risk behaviors.8,9

Current treatment guidelines10 recommend that ART be initiated when patients’ CD4 counts drop below 350 cells/mm3. Those guidelines also indicate that there may be longer-term medical benefits to patients11 and reduced risk of HIV transmission to others when patients are offered ART at earlier stages of disease (CD4 counts >350 cells/mm3). While there are potential risks of early ART (e.g., drug toxicities, development of drug resistance), early ART leading to suppressed viral load may play an important role in reducing HIV transmission, especially among those with on-going risk behaviors.

4. Contemplated Project Requirements.

I. Plan For Integrating Protocol At Clinic Site o A Primary Investigators meeting will be conducted to discuss the clinic-specific issues in integrating the study into the clinic setting and to establish communication protocols. CDC

COTR will provide draft study protocol document. This meeting shall take place at CDC

Atlanta, GA o The contractor shall coordinate and participate in bi-weekly telephone conference calls with the CDC COTR to communicate progress in the plans/project for integrating the protocol into its specific clinic setting.

o Within 20 days of the Primary Investigators meeting, the contractor shall independently prepare written comments regarding clinic-specific issues in integrating all aspects of the protocol into their clinic setting. CDC and the contractor will document comments and finalize the protocol.

o The CDC COTR will provide a draft of the cohort questionnaire to the contractor following the investigators meeting. The contractor shall independently prepare written comments regarding the questions, response alternatives, and formats in the questionnaire and send to the CDC COTR.

o The contractor shall subject the intervention materials to a Program Review Panel. The contract shall submit a signed copy of the Program Review Panel document attesting to the

Panel’s review of intervention materials. CDC COTR will provide the form.

II. Get IRB Approval, Create Study Operations Manual, and Piloting o The contractor shall receive the CDC-approved protocol and modify its format according to the required format for submission to the local-site IRB. Following local-site approval, contractor shall deliver to CDC the IRB approval letter and a copy of the IRB-approved consent form with approval and date indicated.

o Attend an Investigators meeting: Purpose is to meet with CDC COTR and other CDC project staff to discuss their final site preparation for integrating the study into the clinic setting and delineation of roles and responsibilities. This meeting shall take place at CDC Atlanta, GA.

o The CDC COTR will provide a draft of the study operations manual to the contractor. Within

20 days after receiving the draft, the contractor shall independently prepare written comments regarding the specific descriptions of how all aspects of the study have been integrated into the clinic setting and send to the CDC COTR. CDC and the contractor will document comments and finalize the study operations manual.

o Pilot Test a Cohort Questionnaire and Provide Written Comments: The CDC COTR will provide the contractor with the cohort questionnaire to be pilot tested. The contractor shall select six patients at the HIV clinic to pilot test the questionnaire and provide written feedback to the CDC COTR on refinements that need to be made within 14 days of the final pilot-test patient. The six pilot patients shall represent at least two racial-ethnic backgrounds; include gay or bisexual men, heterosexual men, and women.

III. Provide Intervention to HIV+ patients:

o Minimum Patient Sample Size and the Clinic Site’s Minimum Qualification: The contractor’s selected HIV clinic must currently serve at least 900 unduplicated HIV+ patients who have attended the clinic for HIV primary medical care in the most current 12-month period preceding submission of the award. The minimum acceptable count of 900 unduplicated HIV+ primary care patients must all be served by a single, physical clinic location (satellite and part-time remote clinics must not be included in the count).

o Primary care providers shall deliver brief messages about safer sex, adherence, and clinic attendance to patients when they present for primary care exams. Patients shall be re-engaged with prevention messages when they return for primary care visits.

o The contractor shall develop and implement a plan to integrate the delivery of a computerized intervention into the routine care of patients such that all patients receive the intervention at least once a year. Some patients with persistent risks may need multiple exposures to the computerized intervention. The plan shall include a strategy to accommodate several patients simultaneously using multiple computer stations dedicated to delivery of the intervention. The computerized intervention will contain modules on adherence, retention in care, and safer sex.

o To identify higher-risk patients who may need more intensive intervention, a brief behavioral screener (developed by CDC and NIMH) shall be administered either by clinic staff or by computer/electronic device to all patients each time they present for primary care exams (but not more often than on a quarterly basis). The information will help identify the specific prevention needs of patients and to identify patients who need more intensive targeted interventions for sexual risk, sub-optimal adherence, or missed clinic appointments.

o Patients who do not have an undetectable viral load shall be identified for the purpose of targeted intervention to improve adherence, retention in care, or both, as needed.

o The contractor shall develop and implement a plan to administer face-to-face intervention

(e.g., using a prevention specialist) with patients who exhibit persistent risk (e.g., not following their treatment plan, continuing to engage in unsafe sexual behaviors) after multiple exposures to the computerized intervention. The prevention specialist may need to ask some patients to identify a support person (e.g., family member, friend) who will play a role in helping the patient stay adherent to ART and attend clinic as recommended by their medical provider.

o Referrals to case managers, social workers, or psychologists shall be made when necessary to assist patients with unmet needs regarding transportation, housing, substance use, mental health, etc. The Medical Director at the clinic will be asked to discuss with clinical staff the current ART treatment guidelines and encourage clinicians to seriously consider using early ART with patients who can benefit medically and to help prevent transmission of

HIV infection.

o Providers will receive information (prepared by CDC) about the current ART treatment guidelines.

o Patients will receive a brochure (developed by CDC) that includes messages about prevention behaviors, including early ART and its benefits and risks.

o Other materials (developed by CDC) to be used in the intervention include prevention posters that shall be displayed in all exam rooms and the waiting room.

o Documentation of delivery of all aspects of the intervention (screening, brief messages, targeted interventions, discussions with clinicians about early ART) including time spent on these activities is required. This information will be used by CDC to conduct a cost-effectiveness analysis of the intervention components.

IV. Study the Implementation and Outcome Data o The intervention will be implemented and tested at the HIV primary care clinics. It will be evaluated with (1) data collected from a cohort of patients followed across time and (2) data from clinic databases containing information on all patients in the clinic.

o Prior to the onset of the intervention, the clinics will enroll a cohort of 250 sexually active patients and obtain baseline outcome measures. The outcome measures are:

Baseline outcome data (from clinic databases) for all clinic patients:

Individual-level clinic attendance for primary care during the 12 months immediately preceding cohort enrollment

Individual-level HIV clinical data during the 12 months immediately preceding cohort enrollment, including CD4 cell counts, viral load levels, whether patient is on ART, and STI diagnoses.

Baseline outcome data from cohort members only:

Computer-administered behavioral questionnaire at time of enrollment.

o Six clinics will be utilized. Three clinics (Panel A clinics) will begin the intervention immediately after cohort enrollment and baseline data are collected. The other three clinics

(Panel B clinics) will delay onset of the intervention for 12 months and thus serve as a control group for between-panel comparisons during that time.

o The contractor shall obtain and transmit to CDC the baseline data stated previously. Follow-up outcome data described below will also be transmitted to CDC:

Follow-up outcome data (from clinic databases) for all clinic patients during reporting periods:

Individual-level attendance for primary care

Individual-level HIV clinical variables including CD4 cell counts, viral load levels, whether patient is on ART, and STI diagnoses.

Follow-up outcome data for cohort members only:

Computer-administered behavioral questionnaire administered in 6-month intervals throughout the intervention period o Data for each patient shall be identified with a unique study identification number.

V. Patient Exit Interviews and Periodic Provider Surveys: To confirm the delivery and fidelity of the intervention, patients and medical care providers are to be surveyed quarterly. CDC will develop these surveys. Patients are to be surveyed at the clinic after they exit their primary care exam. The patient surveys will include items on whether prevention messages were delivered during the exam, patient’s attitudes about ART, as well as other issues. The provider surveys will include questions on providers’ attitudes and practices regarding early ART as well as questions about whether they are delivering prevention messages to their patients.

VI. Patient-Partner Survey/Interview Study (All six clinics): All six clinics will participate in this survey/interview study. The contractor shall enroll 50 patients at the clinic (the number of men and women enrollees being proportionate to their distribution at the clinic) who are in a primary sexual relationship (at least six months duration) and are able to participate along with their partner in a survey and semi-structured interview. The contractor shall enroll both seroconcordant and serodiscordant partnerships. The intent of this patient-partner survey is to assess support for ART adherence and clinic attendance, barriers, risk-reduction strategies, behavioral changes after starting ART (among those who recently started therapy), communication dynamics, prevention attitudes, and knowledge and attitudes about super infection (if the partner is HIV-positive).

5. References:

1. Marks G, Crepaz N, Janssen RS. Estimating sexual transmission of HIV from persons aware and unaware that they are infected with the virus in the United States. AIDS, 2006;20:1447-1450.

2. Centers for Disease Control and Prevention. Surveillance Report.

www.cdc.gov/hiv/topics/surveillance/resources/reports/2005supp_vol11no2.

3. Gardner L, Metsch L, Anderson-Mahoney P, Loughlin A, del Rio C, Strathdee S, Sansom S, Siegal A et al. Efficacy of a brief case management intervention to link recently diagnosed HIV-infected persons to care. AIDS 2005; 19: 423-431.

4. Kazi S, Boroumand S. Assessing quality of primary care provided to the HIV-infected Ryan White population in the Baltimore eligible metropolitan area. Am J Med Qual 2008,23:484-491.

5. Craw JA, Gardner LI, Marks G, Rapp RC, Bosshart J, Duffus WA, Rossman A, Coughlin SL, Gruber D, Safford LA, Overton, J, Schmitt K. Brief strengths-based case management promotes entry into HIV medical care: results of the Antiretroviral

Treatment Access Study-II (ARTAS-II). JAIDS, 2008;47:597-606.

6. Samet J, Freedberg K, Savetsky J, Padmanabhan L and Stein M. Discontinuation from HIV medical care: squandering treatment opportunities. Journal of Health Care for the Poor and Underserved 2003;14:244-255.

7. Giordano TP, Gifford AL, White AC, Suarez-Almazor ME, Rabeneck L, Hartment C, et al. Retention in care: a challenge to survival with HIV infection. Clin Infect Dis 2007;44:1493-1499.

8. Quinn TC, Wawer MJ, Sewankambo N, Servadda D, Chuanjun L, Wabwire-Mangen F, et al. Viral load and heterosexual transmission of human immunodeficiency virus type 1. N Engl J Med 2000;342:921-929.

9. Tovanabutra S, Robison V, Wongtrakul J, Sennum S, Suriyanon V, Kingkeow D, et al. Male viral load and heterosexual transmission of HIV-1 subtype E in northern Thailand. J Acquir Immune Defic Syndr 2002;29:275-283.

10. Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents.

Developed by the DHHS Panel on Antiretroviral Guidelines for Adultsand Adolescents – A Working Group of the Office of AIDS

Research Advisory Council (OARAC), December, 2009.

http://www.cdc.gov/hiv/topics/surveillance/resources/reports/2005supp_vol11no2

11. Gras L, Kesselring AM, Griffin JT, et al. CD4 cell counts of 800 cells/mm3 or greater after 7 years of highly active antiretroviral therapy are feasible in most patients starting with 350 cells/mm3 or greater. J Acquir Immune Defic Syndr

2007;45:183-92 .