FHI 360, South Africa
||Clinical Data Collection for a randomized study evaluating an intervention integrating economic strengthening and HIV prevention programs for vulnerable youth in South Africa|
May 14, 2015
The ASPIRES Project
The key dates for this RFP process are shown below:
May 14, 2015 - RFP released to potential subcontractors.
May 22, 2015 - Submission of proposal due by 5 pm EST via email to Whitney Moret at email@example.com and copy to Meredith Cann at firstname.lastname@example.org.
June 4, 2015 - Selected candidate notified.
Dec 1, 2015 - Anticipated contract start date. Start date is subject to change.
The purpose of this Request for Proposals (RFP) is to solicit applications to collect and test biological samples for common sexually transmitted infections (STIs) and pregnancy, and provide referrals for treatment and/or services, as necessary, for research participants in the study “A randomized study evaluating an intervention integrating economic strengthening and HIV prevention programs for vulnerable youth in South Africa.” The Recipient will work in coordination with FHI 360 and a third party data collection firm.
The Accelerating Strategies for Practical Innovation and Research in Economic Strengthening (ASPIRES) project is managed by FHI 360, a non-profit human development organization. ASPIRES supports evidence-based, gender-sensitive programming to improve the economic security and well-being outcomes of vulnerable families and children, particularly those infected with or affected by HIV/AIDS, and others at high risk of acquiring HIV. ASPIRES is funded by the United States Agency for International Development (USAID) and the President’s Emergency Plan for AIDS Relief (PEPFAR), under Award No. AID-OAA-LA-13-00001.
The overarching goal of PEPFAR in South Africa is to support Orphans and Vulnerable Children (OVC) programs that mitigate of the impact of HIV, TB and STIs on orphans and other children made vulnerable by HIV and AIDS and their families. Working in collaboration with five South African implementing partners (IPs), ASPIRES seeks to reduce insecurity and vulnerability of OVC aged 13 to 17 with economic strengthening (ES) interventions. The ES package of activities will focus on adolescents, encouraging savings and building financial literacy and fluency. These activities will be combined with an HIV prevention intervention (informed by technical assistance from ASPIRES) to improve communication skills and HIV knowledge for stronger sexual negotiation skills to realize an AIDS-free generation. The goal of the integrated ES and HIV education intervention is to strengthen the economic capacities of vulnerable adolescents infected and affected by HIV/AIDS and improve their economic security in the longer term with support to access further education, training and entrepreneurial activities. This RFP does not concern the technical assistance or the implementation of the interventions, but rather the evaluation research that will be applied to those interventions with one of the IPs.
In addition to numerous technical assistance activities, ASPIRES proposes a robust research agenda to evaluate these interventions designed to improve economic and health outcomes for HIV-affected households, including the research study titled “A randomized study evaluating an intervention integrating economic strengthening and HIV prevention programs for vulnerable youth in South Africa.” The purpose of this study is to assess whether the integration of an economic strengthening (ES) program with an HIV-prevention education program produces synergistic effects on economic and health outcomes, i.e., do integrated models work? To answer this question, we will conduct a full factorial randomized controlled trial (RCT). By necessity, the study will focus on one pre-selected IP from among the five involved in the project; the selected IP works in the greater Pretoria area, hence all research relevant to this RFP will be focused there. Youth, aged 14-17, from four communities located in the area served by the IP (Mamelodi, Mamelodi East, Nellmapius, and Olievenhoutsbosch), will be randomly assigned to one of four arms: economic strengthening (ES) intervention only, HIV prevention education only, ES + HIV prevention education combined, and no intervention (control). (Table 1)
Table 1. Full factorial RCT design
|ES + HIV prevention||HIV prevention only|
|ES only||No intervention (control)|
The objective of this RFP is to identify a Recipient to, in coordination with FHI 360 and a third party data collection firm, be responsible for collecting and testing biological samples, and provide referrals during the course of the study. The work is scheduled to last under 2 years. The Recipient will collect and test biological samples for sexually transmitted infections (STIs) and pregnancy, notify participants of test results, and provide referrals for treatment and/or services for participants with positive STI or pregnancy results. All testing, notifications, and referrals will follow national regulations. Below is a brief summary of the work plan.
3. SCOPE OF WORK
Participants, youth aged 14-17 (~2,000), will be asked by the Recipient at baseline (enrollment), endline 1 (9 months post-baseline), and endline 2 (18 months post-baseline) visits to provide a first catch urine sample to test for gonorrhea, trichomoniasis and chlamydia infection and, for female participants, pregnancy. The Recipient will also provide STI and pregnancy counseling to the participants during each visit. Study visits will be conducted in schools located in the study communities after school hours and on weekends, including holidays. A third party data collection firm will be responsible for recruitment, obtaining parental/guardian consent and youth participants’ assent, and for conducting in-person interviews with the youth participants prior to sending participants to the Recipient for counseling and urine collection during the study visits.
All procedures should follow written standard operating procedures describing the details of specimen collection, storage, transport, testing and result reporting. All clinical and laboratory staff involved in specimen collection and testing will be trained in these procedures.
The Recipient will conduct testing for gonorrhea, trichomoniasis and chlamydia infection using nucleic acid amplification testing (NAAT) on urine specimens. The Recipient will conduct pregnancy testing on the urine specimens using standard human chorionic gonadotropin (hCG) dipsticks or dip-strips. The laboratory preforming the tests must be ISO 17025 Certified.
The Recipient will notify study participants who have positive STI results as soon as results are available and provide referrals local services for free treatment by qualified medical professionals in accordance with local guidelines. The Recipient will provide participants with information, counseling, health services depending on their results, and will advise participants to notify sexual partners of any positive results. The Recipient will offer participants a script which participants can use in sharing referrals with sexual partners. The Recipient will also provide referrals to participants’ sexual partners if requested. The Recipient will also be responsible for helping to link participants with staff from the IP, should the participant wish, to be accompanied to a clinic for care and treatment. Reporting of STI results will follow national regulations and requirements. For study participants with positive STI results, the Recipient will repeat the STI tests after participants complete the treatment regimen. Participants with negative test results will not be contacted.
STI and pregnancy results will be collected on a paper Case Report Form (CRF) and completed the Recipient. The Recipient will securely transfer completed CRFs to a third party data collection firm or FHI 360 for data entry.
The activities to be conducted under this subcontract must be done in accordance with the approved protocol and standards of research ethics, and any subsequent approved revisions, which provide a detailed description of activities. The Recipient will develop Standard Operating Procedures (SOPs) and revise the SOPs in collaboration with FHI 360 and a third party data collection firm. The Recipient will also provide feedback on the study manual.
Activities under this scope are expected to include:
- Coordinate with appropriate stakeholders and partners in all aspects of project planning, implementation, and monitoring. This includes assistance with the local IRB submission process and any other study-related approvals.
- Liaise with the third party data collection firm to arrange for collecting specimens at the same time as participants are undergoing their in-person interviews. Recruitment, consent/assent, and in-person interviews to be conducted by third party data collection firm.
- In collaboration with other study partners, prepare for and participate in an initial study training for all study staff members on study methods, instruments, and research ethics and relevant post-training activities.
- Collect and test urine specimens from adolescent study participants during each study visit (Baseline, Endline 1, and Endline 2) for gonorrhea, trichomoniasis and chlamydia infection through nucleic acid amplification testing (NAAT) and pregnancy through hCG dipsticks or dip-strips. Participants with positive STI results will be re-tested after treatment is completed. Appropriate and safe handling, storage, and transportation of biological samples required. The laboratory performing the tests must be ISO 17025 Certified.
- Provide counseling and test results to adolescent study participants, and referrals for treatment and services as necessary to participants and to participants’ sexual partners as requested.
- Submit all Case Report Forms regularly to a third party data collection firm or FHI 360 for data entry.
- Work with FHI 360 to document lessons learned and best practices in the data collection and field implementation process; draft and submit written reports on field implementation lessons learned.
- Submit regular work updates and participate in regular calls with FHI 360. Maintain open communication with FHI 360, particularly with respect to any changes in implementation, social harms, or other concerns that may arise.
FHI 360’s ASPIRES Team will be responsible for:
- Formal communications between USAID and the subcontractor
- Development of protocol and Case Report Forms
- Providing study sample
- Oversight of the quality and ethical conduct of the research
- IRB submission in the United States
- Data analysis
- Dissemination of findings
4. WORK PLAN
Below is estimate of the timeline. The Recipient would need to exhibit flexibility in timelines dependent on outside factors.
5. FUNDING AND SUBCONTRACT MECHANISM
The mechanism for funding will be a cost-reimbursement subcontract.
The ceiling for this award is US$615,000.
Proposals must be prepared in English and delivered electronically by 5:00 pm EST in accordance with the instructions on page 1.
All submissions should include:
- Description of methodology and proposed approach for the tasks as described in the Scope of Work section above (max 3 pages) demonstrating:
- Professional experience and credentials.
- Solid experience in collecting and testing biological samples for STIs and pregnancy, and providing counseling and referrals for treatment and services within public health studies. Please indicate if you have experience conducting similar work with adolescent populations and/or in the proposed study sites.
- Solid experience organizing and managing field teams for the tasks described in the Scope of Work.
- Ability to submit and obtain ethics approval (particularly within South Africa) for similar research, or past assistance with the submission process.
- Ability to reach and connect with ethics committees and government officials (to obtain necessary authorizations for collecting and testing biological samples), or past assistance in connecting with these agencies.
Agencies must also provide a description of location(s) of presence relevant to this RFP. Agencies with research experience in the greater Pretoria area are preferred.
- A summary (max. 2 pages) of expertise and experience, highlighting those aspects that are
particularly relevant to the present assignment.
- CV or resume (5 pages maximum each) for key personnel.
- Name and contact details for three relevant references.
- Workplan and timeline for completing required tasks.
- Budget and budget narrative, including:
- A detailed line item budget, budget narrative, and supporting documentation that clearly describe how the budgeted amounts are calculated must support the applicant’s budget. A brief narrative explanation and justification for each line item must be included in a separate section entitled “budget narrative” and include data to support actual costs and/or methodologies to support cost estimates. The budget narrative serves as justification for each cost included in a budget; should be presented in such a way as to be easily referenced from the budget; and should provide sufficient information so that FHI 360 may review a proposed budget for reasonableness. All projected costs must be in accordance with the organization’s standard practices and policies.
- Budgets must be sufficiently detailed to demonstrate reasonableness and completeness. Applications including budget information determined to be unreasonable, incomplete, unnecessary for the completion of the proposed project, or based on a methodology that is not adequately supported may be deemed unacceptable.
- Budgets should be submitted in applicant’s local currency. Please note that FHI 360 cannot honor exchange rates included in a budget. Payments will be made according to the exchange rate at the time of payment.
- Please indicate the inclusion/exclusion of any applicable taxes such as VAT.
FHI 360/ASPIRES will accept questions from interested parties through 5:00 pm EST on the date noted on Page 1. Questions will only be accepted in writing. All emailed questions must contain the subject line “FHI 360/ASPIRES – RCT 1 Clinical.”
7. EVALUATION CRITERIA
Applications received under this Request will be evaluated and ranked by a committee, in accordance with the following criteria:
- Capabilities and Experience: reflects understanding of the ASPIRES scope and matches firm's capacities with required activities
- Geographical experience
- Experience collecting and testing biological samples, and providing counseling and referrals (STIs preferred)
- Experience working with other organizations, locally and internationally
- Personnel: relevance of organizational experience to the proposed task.
- Key personnel qualifications
- Past Performance
- At least three strong references demonstrated success working with biological samples
- Cost reasonableness: proposed price costs reflect a clear understanding of the requirements stated in this RFP, and are consistent with the various elements of the application.
- Proposed price is reasonable in comparison with proposed prices received in response to the solicitation.
|Capabilities and Past Performance/Experience||40|
Disclaimers and FHI 360 Protection Clauses
- FHI 360 may cancel solicitation and not award.
- FHI 360 may reject any or all responses received.
- Issuance of solicitation does not constitute award commitment by FHI 360.
- FHI 360 reserves the right to disqualify any offer based on offeror failure to follow solicitation instructions.
- FHI 360 will not compensate offerors for response to solicitation.
- FHI 360 reserves the right to issue award based on initial evaluation of offers without further discussion.
- FHI 360 may choose to award only part of the activities in the solicitation, or issue multiple awards based on the solicitation activities.
- FHI 360 reserves the right to waive minor proposal deficiencies that can be corrected prior to award determination to promote competition.
- FHI 360 will be contacting offerors to confirm contact person, address and that bid was submitted for this solicitation.