title: Developing standards of care for HIV prevention research in developing countries -- a case study of 10 research centers in Eastern and Southern Africa.
abstract: 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.
authors.affiliation: International AIDS Vaccine Initiative, Country and Regional Programs, New York, USA. pbahati@iavi.org
authors.forename: Prince Bahati
authors.initials: PB
authors.lastname: Ngongo
authors.forename: Frances
authors.initials: F
authors.lastname: Priddy
authors.forename: Harriet
authors.initials: H
authors.lastname: Park
authors.forename: Julie
authors.initials: J
authors.lastname: Becker
authors.forename: Bonnie
authors.initials: B
authors.lastname: Bender
authors.forename: Pat
authors.initials: P
authors.lastname: Fast
authors.forename: Omu
authors.initials: O
authors.lastname: Anzala
authors.forename: Gaudensia
authors.initials: G
authors.lastname: Mutua
authors.forename: Eugene
authors.initials: E
authors.lastname: Ruzagira
authors.forename: Anatoli
authors.initials: A
authors.lastname: Kamali
authors.forename: Etienne
authors.initials: E
authors.lastname: Karita
authors.forename: Peter
authors.initials: P
authors.lastname: Mugo
authors.forename: Elwyn
authors.initials: E
authors.lastname: Chomba
authors.forename: Linda-Gail
authors.initials: LG
authors.lastname: Bekker
authors.forename: Surita
authors.initials: S
authors.lastname: Roux
authors.forename: Annet
authors.initials: A
authors.lastname: Nanvubya
authors.forename: Tsedal
authors.initials: T
authors.lastname: Mebrahtu
mesh_terms: D000351:Africa, Eastern / Q000453:epidemiology; D000353:Africa, Southern / Q000453:epidemiology; D018791:CD4 Lymphocyte Count; D016022:Case-Control Studies; D003376:Counseling / Q000592:standards*; D003695:Delivery of Health Care; D005193:Family Planning Services / Q000592:standards*; D005260:Female; D015658:HIV Infections / Q000188:drug therapy / Q000453:epidemiology*; D006302:Health Services Research / Q000458:organization & administration*; D006801:Humans; D008297:Male; D010342:Patient Acceptance of Health Care / Q000706:statistics & numerical data*; D040242:Risk Reduction Behavior; D059039:Standard of Care / Q000706:statistics & numerical data*