Design and concepts of the NIMH Collaborative HIV/STD Prevention Trial
van Griensven, Frits; Kalichman, Seth C
The scope of the AIDS pandemic demands a systematic approach to implementing multiple levels of prevention strategies to control the spread of HIV infection. On the individual level, voluntary counseling and testing (VCT) remains the frontline in HIV prevention. With effective HIV risk reduction counseling, there are clear preventive effects in conjunction with VCT , and risk reduction counseling can be effective independent of VCT . Similarly, risk reduction interventions delivered to small groups of at risk persons demonstrate significant preventive benefits in carefully controlled trials . The greatest concern with implementing these effective individual-level behavioral interventions is that people who are counseled inevitably return to their unchanged social and risk environments where risk-taking practices are normative and socially reinforced. Interventions, such as microbicides, pre-exposure antiretroviral prophylaxis, diagnosis and treatment of sexually transmitted infections, and male circumcision may lead to population level reductions in HIV/AIDS risk, but their effects will be limited if compensating behaviors are not contained and exposure behaviors are kept at least constant . Interventions that structurally alter the social context within which sexual and drug using behaviors occur are therefore necessary for facilitating, supporting, and maintaining HIV risk behavior change.
The NIMH Collaborative HIV/STD Prevention Trial is the first multi-site randomized community-level HIV prevention intervention study with behavioral and biological endpoints in international settings. The intervention under study is grounded in sound theories of disease prevention behavior change. Social Cognitive Theory  is the foundation for social and communication skills training that is conducted with community identified opinion leaders who are trained to become agents of change in their community. A critical mass of opinion leaders ultimately circulate in their community and through their conversations with peers, influence behavior change. The structural changes in social norms and perceptions occur through a systematic process detailed by the Theory of Diffusion of Innovations . The tenants of Social Cognitive Theory and the Theory of Diffusion of Innovations are highly complementary and are actually unified in their approach . The intervention being tested has been demonstrated effective in studies with diverse populations in the US [8–11]. The NIMH Trial is testing the intervention in China, India, Peru, Russia and Zimbabwe.
This Supplement issue of AIDS provides detailed reports on the design and concepts of the NIMH Trial. Papers in this volume offer important insights into the many facets of this complicated study. Each aspect of the study protocol is discussed in detail in these papers including the early formative and ethnographic studies, the adaptation of the intervention for use across cultures, behavioral and biological assessment protocols, and research ethics. This collection of articles describes the essential background and underpinnings of the trial. This volume is expected to serve as a resource to understand the trial design and to interpret the study outcomes when they are available. In addition, it is hoped that this volume and its papers will serve as an invaluable reference for the design and planning of future HIV prevention research.
1. Kamb ML, Fishbein M, Douglas JM Jr, Rhodes F, Rogers J, Bolan G, et al
. Efficacy of risk-reduction counseling to prevent human immunodeficiency virus and sexually transmitted diseases: a randomized controlled trial. Project RESPECT Study Group. JAMA 1998; 280:1161–1167.
2. Kalichman SC, Simbayi LC, Vermaak R, Cain D, Jooste S, Peltzer K, Habilis D. HIV/AIDS risk reduction counseling for alcohol using sexually transmitted infections clinic patients in Cape Town, South Africa
. J Acquir Immune Defic Syndr
2007 Feb 22, epub ahead of print.
3. The National Institute of Mental Health (NIMH) Multisite HIV Prevention Trial Group. The NIMH multisite HIV prevention trial: reducing HIV sexual risk behavior
4. Baggaley RF, Garnett GP, Ferguson NM. Modelling the Impact of antiretroviral use in resource-poor settings. PLoS Med 2006; 3:e124.
5. Bandura A. Self-efficacy: the exercise of control
. New York: Freeman; 1997.
6. Rogers EM. Diffusion of Innovations
. 4th ed. New York: Free Press; 1995.
7. Winett RA, Anderson ES, Desiderato LL, Solomon LJ, Perry M, Kelly JA, et al
. Enhancing social diffusion theory as a basis for prevention intervention: a conceptual and strategic framework. Applied Prev Psych 1995; 4:233–245.
8. Kelly JA, Murphy DA, Sikkema KJ, McAuliffe TL, Roffman RA, Solomon LJ, et al
. Randomized, controlled, community-level HIV prevention intervention for sexual risk behaviour among homosexual men in U.S. cities. Lancet 1997; 350:1500–1505.
9. Kelly JA, St. Lawrence JS, Stevenson LY, Hauth AC, Kalichman SC, Diaz YE, et al
. Community AIDS/HIV risk reduction: the effects of endorsements by popular people in three cities. Am J Public Health 1992; 82:1483–1489.
10. Sikkema KJ, Kelly JA, Winett RA, Solomon LJ, Cargill VA, Roffman RA, et al
. Outcomes of a randomized community-level HIV prevention intervention for women living in 18 low-income housing developments. Am J Public Health 2000; 90:57–63.
11. Miller RL, Klotz D, Eckholdt HM. HIV prevention with male prostitutes and patrons of hustler bars: replication of an HIV prevention intervention. Am J Community Psychol 1998; 26:97–131.
© 2007 Lippincott Williams & Wilkins, Inc.