Global Health Diplomacy, Monitoring & Evaluation, and the Importance of Quality Assurance & Control: Findings from NIMH Project Accept (HPTN 043): A Phase III Randomized Controlled Trial of Community Mobilization, Mobile Testing, Same-Day Results, and Post-Test Support for HIV in Sub-Saharan Africa and Thailand.

BACKGROUND: Provision and scale-up of high quality, evidence-based services is essential for successful international HIV prevention interventions in order to generate and maintain intervention uptake, study integrity and participant trust, from both health service delivery and diplomatic perspectives. METHODS: We developed quality assurance (QAC) procedures to evaluate staff fidelity to a cluster-randomized trial of the NIMH Project Accept (HPTN 043) assessing the effectiveness of a community-based voluntary counseling and testing strategy. The intervention was comprised of three components-Mobile Voluntary Counseling and Testing (MVCT), Community Mobilization (CM) and Post-Test Support Services (PTSS). QAC procedures were based on standardized criteria, and were designed to assess both provider skills and adherence to the intervention protocol. Supervisors observed a random sample of 5% to 10% of sessions each month and evaluated staff against multiple criteria on scales of 1-5. A score of 5 indicated 100% adherence, 4 indicated 95% adherence, and 3 indicated 90% adherence. Scores below 3 were considered unsatisfactory, and protocol deviations were discussed with the respective staff. RESULTS: During the first year of the intervention, the mean scores of MVCT and CM staff across the 5 study sites were 4 (95% adherence) or greater and continued to improve over time. Mean QAC scores for the PTSS component were lower and displayed greater fluctuations. Challenges to PTSS staff were identified as coping with the wide range of activities in the PTSS component and the novelty of the PTSS process. QAC fluctuations for PTSS were also associated with new staff hires or changes in staff responsibilities. Through constant staff monitoring and support, by Year 2, QAC scores for PTSS activities had reached those of MVCT and CM. CONCLUSIONS: The implementation of a large-sale, evidence based HIV intervention requires extensive QAC to ensure implementation effectiveness. Ongoing appraisal of study staff across sites ensures consistent and high quality delivery of all intervention components, in keeping with the goals of the study protocol, while also providing a forum for corrective feedback, additional supervision and retraining of staff. QAC ensures staff fidelity to study procedures and is critical to the successful delivery of multi-site HIV prevention interventions, as well as the delivery of services scaled up in programmatic situations.

Health diplomacy and the adaptation of global health interventions to local needs in sub-Saharan Africa and Thailand: evaluating findings from Project Accept (HPTN 043).

BACKGROUND: Study-based global health interventions, especially those that are conducted on an international or multi-site basis, frequently require site-specific adaptations in order to (1) respond to socio-cultural differences in risk determinants, (2) to make interventions more relevant to target population needs, and (3) in recognition of 'global health diplomacy' issues. We report on the adaptations development, approval and implementation process from the Project Accept voluntary counseling and testing, community mobilization and post-test support services intervention. METHODS: We reviewed all relevant documentation collected during the study intervention period (e.g. monthly progress reports; bi-annual steering committee presentations) and conducted a series of semi-structured interviews with project directors and between 12 and 23 field staff at each study site in South Africa, Zimbabwe, Thailand and Tanzania during 2009. Respondents were asked to describe (1) the adaptations development and approval process and (2) the most successful site-specific adaptations from the perspective of facilitating intervention implementation. RESULTS: Across sites, proposed adaptations were identified by field staff and submitted to project directors for review on a formally planned basis. The cross-site intervention sub-committee then ensured fidelity to the study protocol before approval. Successfully-implemented adaptations included: intervention delivery adaptations (e.g. development of tailored counseling messages for immigrant labour groups in South Africa) political, environmental and infrastructural adaptations (e.g. use of local community centers as VCT venues in Zimbabwe); religious adaptations (e.g. dividing clients by gender in Muslim areas of Tanzania); economic adaptations (e.g. co-provision of income generating skills classes in Zimbabwe); epidemiological adaptations (e.g. provision of 'youth-friendly' services in South Africa, Zimbabwe and Tanzania), and social adaptations (e.g. modification of terminology to local dialects in Thailand: and adjustment of service delivery schedules to suit seasonal and daily work schedules across sites). CONCLUSIONS: Adaptation selection, development and approval during multi-site global health research studies should be a planned process that maintains fidelity to the study protocol. The successful implementation of appropriate site-specific adaptations may have important implications for intervention implementation, from both a service uptake and a global health diplomacy perspective.

No "magic bullet": exploring community mobilization strategies used in a multi-site community based randomized controlled trial: Project Accept (HPTN 043).

As community-level interventions become more common in HIV prevention, processes such as community mobilization (CM) are increasingly utilized in public health programs and research. Project Accept, a multi-site community randomized controlled trial, is testing the hypothesis that CM coupled with community-based mobile voluntary counseling and testing and post-test support services will alter community norms and reduce the incidence of HIV. By using a multiple-case study approach, this qualitative study identifies seven major community mobilization strategies used in Project Accept, including stakeholder buy-in, formation of community coalitions, community engagement, community participation, raising community awareness, involvement of leaders, and partnership building, and describes three key elements of mobilization success.

Removing barriers to knowing HIV status: same-day mobile HIV testing in Zimbabwe.

OBJECTIVES: We developed a mobile HIV voluntary counseling testing (VCT) strategy. Our aims were (1) to describe those using the services, (2) to assess the acceptability of such services, (3) to assess reasons for not testing previously, and (4) to compare those who used the services with those who did not to determine how to increase acceptability. METHODS: We provided free anonymous mobile VCT using 2 rapid HIV tests in 12 marketplaces in Epworth and Seke, Zimbabwe. Qualitative interviews were conducted to assess motivations for and barriers to testing. A subsample of HIV testers and individuals near testing vans who declined testing (nontesters) completed a questionnaire. RESULTS: A total of 1099 individuals participated in mobile VCT between March 2002 and August 2003. The proportion of participants infected with HIV was 29.2%. Overall, 98.8% of participants elected to receive HIV test results the same day. Reasons for not testing previously were often logistic (eg, inconvenience of hours [25.6%] and location [20.7%] or cost [8%]). Those who used the same-day mobile testing services (testers vs. nontesters) perceived themselves at higher risk for HIV infection (adjusted odds ratio [AOR] = 1.8) but were less likely to have known people with HIV (AOR = 0.49) or where to get tested (AOR = 0.57). CONCLUSIONS: Same-day HIV testing in community settings seems to be acceptable in sub-Saharan Africa. Barriers to HIV testing are often logistic and can be overcome with community-based strategies. These strategies need to be refined to address the needs of those not using mobile testing services.

Vaginal microbicides for HIV/STI prevention in Zimbabwe: what key informants say.

The purpose of this study was to assess the acceptability of vaginal microbicides as prevention methods for heterosexually transmitted HIV. Interviews were conducted with key informants in and around Harare using a semistructured questionnaire with probes. Twenty-seven interviews were conducted with a total of 48 informants. Most women were enthusiastic about the products but had concerns about safety and how the use of these products might affect their relationships with their husbands. Many men were concerned that women would be able to use the products without their consent or knowledge. Several products may be acceptable in this culture but must be introduced within the existing gender power structure. This study provides a model for involving community leaders in the design of culturally appropriate clinical trials.