Developing standards of care for HIV prevention research in developing countries -- a case study of 10 research centers in Eastern and Southern Africa.

Standards of care provided to volunteers in HIV prevention research in developing countries are evolving. Inconsistency in standards, particularly within a research network highlights the need to balance volunteers' health and wellness with the efficient conduct of research. Ten research centers (RC's) in East and Southern Africa affiliated with the International AIDS Vaccine Initiative (IAVI) were studied using a mixed methods approach to understand variations, similarities and gaps in services provided, recipients of services, referral systems, and barriers to referral uptake. These data were then used to develop expected standards across the 10 RCs. Findings indicated that RCs consistently provided HIV risk reduction and family planning (FP) counseling, male condoms, management of sexually transmitted infections, CD-4 counts, and general medical care to volunteers and non-research volunteers. Services that were less consistently provided on-site included: female condoms, adult male circumcision (AMC), antiretroviral therapy (ART) and post-exposure prophylaxis (PEP) in case of rape. The FP options provided on-site varied, with few providing implants, intrauterine devices, tubal ligation, and vasectomy. Most RCs had established referral systems for ART, AMC, PEP, and FP, but few had referral points for psychosocial services. Few RCs had comprehensive guidelines on referrals other than those related to adverse events. Findings indicate that the greatest challenges for referral uptake were transportation and health care costs, poor quality and inconsistency of services at some referral points. Few RCs covered the cost of referrals for non-study related adverse events. A collaborative process between IAVI and the RCs was undertaken to reach consensus on expected standards of care. A set of required and recommended services to be provided on-site or by referral was developed. In developing such standards, we tried to balance scientific priorities, equity, contextual realities, community expectations, and cost-effectiveness.

Ensuring quality of services in HIV prevention research settings: findings from a multi-center quality improvement pilot in East Africa.

Quality improvement (QI) has been widely implemented in health services but has not been widely applied in HIV prevention research. Most prevention research centers have commonly employed traditional approaches (e.g., checklists) to quality control that document what has been done but not the quality of what has been done. Unlike other health settings, prevention research settings have unique characteristics and ethical requirements that require the development or adaptation of specific quality indicators. A QI model for health services was adapted for use in prevention research settings and was piloted between August 2006 and July 2007 at three research centers in East Africa. Four hundred and twenty-six volunteers exit interviews were administered in two cycles. Quantitative and qualitative data were analyzed using Excel worksheets. QI meeting reports and QI plans were used to complement data from exit interviews. On average, 52% of total enrolled volunteers participated in the exit interview. The designed QI plans successfully helped reduce volunteers' reported waiting time to see counselors (p<0.001) and pharmacists (p<0.001). It also increased the percentage of interviewed volunteers who reported being counseled on family planning at clinical trials (from 66 to 93%; p=0.02) at follow-up visits, and who were refreshed on informed consent at follow-up visits (from 90 to 96%; p=0.009). The percentage of interviewed volunteers that expressed satisfaction with services received from counselors increased (from 87 to 94%; p=0.009) while the percentage of volunteer satisfied with services from trial physicians remained constant (93%). The majority of volunteers interviewed reported satisfaction with other major components of research such as confidentiality, understanding of trial objectives, benefits and risks of participation, and risk reduction counseling. However, satisfaction with services from community outreach workers and other staff at research centers dropped over the course of the study (from 88% in Cycle 1 to 74% in Cycle 3; p= < 0.001). Increased commitment to QI is crucial in ensuring quality of services and ethical conduct of HIV prevention research centers.

Men who have sex with men sensitivity training reduces homoprejudice and increases knowledge among Kenyan healthcare providers in coastal Kenya.

INTRODUCTION: Healthcare workers (HCWs) in Africa typically receive little or no training in the healthcare needs of men who have sex with men (MSM), limiting the effectiveness and reach of population-based HIV control measures among this group. We assessed the effect of a web-based, self-directed sensitivity training on MSM for HCWs (www.marps-africa.org), combined with facilitated group discussions on knowledge and homophobic attitudes among HCWs in four districts of coastal Kenya. METHODS: We trained four district "AIDS coordinators" to provide a two-day training to local HCWs working at antiretroviral therapy-providing facilities in coastal Kenya. Self-directed learning supported by group discussions focused on MSM sexual risk practices, HIV prevention and healthcare needs. Knowledge was assessed prior to training, immediately after training and three months after training. The Homophobia Scale assessed homophobic attitudes and was measured before and three months after training. RESULTS: Seventy-four HCWs (68% female; 74% clinical officers or nurses; 84% working in government facilities) from 49 health facilities were trained, of whom 71 (96%) completed all measures. At baseline, few HCWs reported any prior training on MSM anal sexual practices, and most HCWs had limited knowledge of MSM sexual health needs. Homophobic attitudes were most pronounced among HCWs who were male, under 30 years of age, and working in clinical roles or government facilities. Three months after training, more HCWs had adequate knowledge compared to baseline (49% vs. 13%, McNemar's test p<0.001); this was most pronounced in those with clinical or administrative roles and in those from governmental health providers. Compared to baseline, homophobic attitudes had decreased significantly three months after training, particularly among HCWs with high homophobia scores at baseline, and there was some evidence of correlation between improvements in knowledge and reduction in homophobic sentiment. CONCLUSIONS: Scaling up MSM sensitivity training for African HCWs is likely to be a timely, effective and practical means to improve relevant sexual health knowledge and reduce personal homophobic sentiment among HCWs involved in HIV prevention, testing and care in sub-Saharan Africa.