Planning process
Implementation of "same-visit" HIV testing in TT was lead by a multidisciplinary technical working group (TWG). The TWG had representation from each administrative entity that would be involved with implementation of "same-visit" HIV testing. Thus the TWG included a broad array of professional expertise: physicians, nurses, laboratory personnel, program managers, counselors and social workers. The TWG also included individuals who provided technical assistance on behalf of both CAREC and CDC/GAP. The TWG diversity incorporated contrasting experiences and expectations about HIV testing. Over time, TWG diversity matured into strength of consensus.
Role of the TWG
The TWG reviewed and identified international best practices for "same visit" HIV testing. These best practices were incorporated into a protocol (Additional file
1), or technical framework, that specified details for implementation of "same-visit" HIV testing in TT. In addition to the protocol, the TWG drafted several other documents including class-room training materials (Additional file
2), a Reference Manual (Additional file
3) for testers, certification criteria (Additional file
4), and a job description for the Ministry post of Quality Monitor.
Challenges
The most formidable challenges in protocol design were contained in the terms "quality" and "same-visit" HIV testing. The Ministry request was for technical assistance with a testing program in which one person, who served as both counselor and tester, could report quality test results that were independent of laboratory confirmation. One of the program goals was to allow non-laboratory personnel to report test results from non-laboratory locations. By requesting technical assistance in this way, the Ministry maximized the potential impact of the testing program. The protocol provided a technical framework by which this program goal could be achieved.
MOH protocol
The TWG reviewed evidence for the Ministry protocol from four sources. The first source was Guyana, another small country in the region. In 2004, Guyana introduced a national program for HIV testing that had many similarities to the program envisioned by Ministry policy advisors in TT. The Ministry of Health Guyana had shared their lessons learned with both CAREC and CDC/GAP. The second source was Brazil; in 2004, Brazil was mid-way in plans to implement national policy for HIV testing. The Brazilian lessons learned provided information from a much larger country in the region. Some of these lessons have since been published [
8]. Experiences and data from both of these countries were used to inform TWG decisions. The third source of information was the PMTCT program in TT. This program had begun collecting data about the performance of HIV rapid tests in TT in 1999; these data were especially useful to the TWG. The fourth source included reference documents and recommendations from both WHO and CDC and other published materials. All sources are referenced in the Ministry protocol (Additional file
1).
In addition to referencing source materials, the Ministry protocol also provided detailed information on several technical topics including: 1) a description of routine testing integrated into a quality monitoring system, 2) the rational for "same-visit" HIV testing, 3) the evidence for the Ministry algorithm selection and 4) guidance for operation of the pilot and 5) guidance for expansion to additional sites.
The Ministry protocol also outlines three concepts that facilitated implementation of "same-visit" testing: 1) people who provide testing must be certified, 2) sites which provide testing must be certified; and 3) a Quality Monitor must provide regular oversight of the testing process.
Certification Process
The essential components of Ministry-certified testing are twofold: site-certification and tester-certification. Site-certification is facility-oriented. The site-readiness checklist (Additional file
5) identifies items that must be ready before testing can begin. Tester-certification is a three-step training program (Additional file
6). Both site- and tester-certification are subject to annual review. The Ministry reserves the right to stop testing in any situation where certification criteria are not met.
Training Program
The protocol stipulates that only testers who are certified may provide "same-visit" HIV testing on behalf of the Ministry. The TWG devoted considerable attention to creating a training program for tester certification. The classroom materials used in the training program were customized from the HIV Rapid Testing Training Package [
9]. The Ministry-customized version of the classroom training materials can be found in Additional file
2. The laboratory training materials were developed by two of the authors of this document (CA and CW) and outlines for these materials are in Additional file
7.
Full certification for Ministry testers is a three-step process (Additional file
6). Each person who is certified to provide testing must complete a training workshop, a laboratory internship and a proficiency exam.
The training workshop is a 3-day event that includes both classroom time (14 hours) and hands-on training (10 hours). During classroom time, workshop participants listen to lectures, participate in group discussions and use teaching aids to increase their interpretative skills. Skill with interpretation of HIV-status according to national testing algorithm is integral to the quality system for "same-visit" HIV testing. In addition, trainees must learn to interpret results from testing quality-control (QC) materials.
During hands-on training, workshop participants were encouraged "to think like lab people". During this training, the ratio of trainees to facilitators was 4:1. Facilitators observed and interacted individually with trainees as they learned the details of testing. Testers must acquire skills that are routine for laboratory staff. During the practical sessions, workshop participants learned to use transfer pipettes, to perform finger-stick blood collection, to use rapid-test devices, to keep accurate records, to conduct routine testing of QC materials and to use the Ministry national algorithm to provide HIV infection status reports.
To integrate quality into "same-visit" HIV testing, each component of training was customized to the Ministry national testing algorithm. The training included use of standard operating procedures (SOPs) for each step of the testing process. All hands-on practical time was SOP-driven. Each workshop participant was given a Reference Manual (Additional file
3) containing all SOPs.
Training workshops included both written and practical examinations. To successfully complete a training workshop, participants were required to score 80% on a written exam and 100% on a practical exam. Sample test questions from the written exams can be found in Additional file
8.
After successfully completing a training workshop, certification-candidates enrolled in a laboratory internship. During the internship, each candidate tested 50 known samples under supervision of a certified tester. A member of the clinical laboratory staff at Port of Spain General Hospital served as supervisor for laboratory interns.
After successfully completing an internship, certification-candidates were required to complete a proficiency exam. The proficiency exam involved accurately testing a panel of unknowns. The unknowns were purchased from an external supplier. Additional information about the panels used for Ministry certification can be found in Additional file
1.
Quality Assurance
The Ministry protocol specifies daily testing of quality control (QC) materials by each person who provides testing. Each tester must test both known positive and negative QC samples with each of the tests in the Ministry algorithm on each day of testing. This means that daily QC testing requires 6 tests per tester per site and the total daily cost of testing must include costs of these supplies.
Regular testing of QC materials is the most important feature of the quality program described in the Ministry protocol. Results from testing of QC materials must be available each day before testing can begin. If there are problems with the daily QC testing, "same-visit" HIV testing must be halted until the problems are resolved. In addition, these QC test results are regularly reviewed by the Quality Monitor as part of each site audit. These QC test results are essential to trouble shooting problems that arise with decentralized testing. In short, QC sample results are integral to allowing HIV testing to be independent of laboratory confirmation.
Pilot Site Testing
The Ministry selected a newly refurbished public health sector clinic in Port of Spain as the pilot site for "same-visit" HIV testing. Differences existed between what the TWG had discussed as suitable space for HIV testing and what was found at the pilot site. These differences led to the development of a site-readiness checklist (Additional file
5). The manager of the pilot site and others from the TWG oversaw renovations at this site. When the site fulfilled the readiness criteria, it was designated as the pilot site for "same-visit" HIV testing.
After the "same-visit" HIV testing was optimized at the public health sector pilot site, it was expanded to a second site. The second site was an NGO contracted by the Ministry to provide reproductive health services at five locations in TT. The site selected for expansion of testing had facilities that met site-certification criteria and three staff members who had completed Ministry tester-certification. CAREC recommended that this NGO location add "same-visit" HIV testing to its program services. CAREC funded and provided technical oversight to this NGO. CAREC also advocated for national policy that would include NGO provision of "same-visit" HIV testing.