Behavioral Science  Research Strategy

Overview

High-risk behavior is the primary focus of the HPTN Behavioral Science Working Group's research agenda because sexual transmission and injection drug use account for a preponderant number of cumulative and new HIV infections worldwide. Behavioral science plays a role in HIV prevention research not only through continued development and evaluation of behavioral interventions, but also because almost all other HIV prevention strategies have behavioral components, as do comprehensive methods used to assess and evaluate their efficacy.

While individual behavioral scientists participating in HPTN working groups and protocol teams continue to address the behavioral aspects of various biomedical interventions under development, the Behavioral Science Working Group's principal focus is on the further identification, development, and evaluation of behavioral interventions associated with reducing risks of HIV through high-risk behavior.

Background and Rationale

	Unprotected anal and vaginal intercourse and multiple sex partners are key risk factors in HIV transmission.
	Approximately 10% of all HIV infections result from unsafe drug injecting behavior.
	Social and individual contexts may increase risk.  Social norms that influence risk include cultural and religious beliefs, gender norms, and marginalization of populations including gay men, minorities, sex workers and women, especially adolescents.  Individual factors include age and development stage, self-esteem, sexual identity, early initiation of sexual behavior, multiple partners, untreated STDs, partner commitment, and substance use.
	Individual and small group counseling interventions using cognitive and skills training approaches have been shown to reduce HIV risk behaviors in men who have sex with men, heterosexual men and women, heterosexual couples, injecting drug users, and adolescents.
	Achievement of sustained behavior change over extended periods of time is one of the most challenging features of effective behavioral interventions.
	Voluntary counseling and testing has been shown to reduce behavioral risk, especially in HIV infected persons and in extramarital partnerships. The next step, its influence on HIV seroincidence, has not yet been demonstrated.
	Results of large-scale trials of community level interventions with HIV seroincidence as the primary outcome have not been reported, although limited research in this area is underway with support through other funding mechanisms. Influencing community norms rather than individuals is the focus of these trials.
	Behavioral interventions must be integrated into existing prevention programs and biomedical interventions.

Key Public Health Questions identified by the working group

	Can a behavioral intervention implemented at the community-level have an effect on HIV incidence?
	What effect does saturation of voluntary counseling and testing have on community transmission rates? Under what circumstances is an associated increase in disclosure and/or decrease in stigma associated with reduction in HIV incidence, and what implications does this have for the nature of interventions that would be able to effect further reductions in HIV incidence?
	Under what conditions do behavioral interventions that have shown efficacy in reducing self-reported risk behaviors or surrogate STDs have a similar effect on HIV incidence?
	What is the most effective way to reach HIV infected individuals to reduce the transmission of HIV to their sex partner(s)?
	What is the best way to communicate the concept of “partial effectiveness” of clinical HIV prevention strategies to study participants and the general population?

Future Directions 

The BSWG has identified several areas for needed research and advocacy. The working group believes that several areas for future research would benefit from collaboration with other working groups and utilization of populations from existing ongoing or completed studies.

Integrating Care and Prevention: We need to develop a model for integrating care and prevention, particularly in clinical settings. It is clear that prevention can no longer be viewed in isolation or as the only thing we have now that HAART or ART will soon be widely available. The HPTN BSWG research agenda would require new conceptualizations of how to do prevention better in clinical settings. One focus might be placed upon the uninfected partner in HIV discordant couples and the secondary prevention needs of HIV infected individuals. 

Transactional Sex is an area of importance both internationally and in the United States. Research should focus on both the men and women 'selling' sex and those who are 'purchasing' it. This means of transmission may be sufficient to maintain an epidemic in areas where prevention improvements have been seen. 

Randomized Clinical Trial (RCT) of existing HIV prevention programs: HIV prevention programs that encourage behavior change, such as condom social marketing and abstinence-only education, are widely promoted, though little empirical evidence exists about their efficacy. A randomized trial of these programs versus competing programs, such as comprehensive sex education, with HIV and other STD endpoints could help lead to evidence-based policies. 

Microbicides are a significant area of clinical HIV prevention research that could benefit from behavioral components. The BSWG plans to work with the Microbicides Working Group to develop studies related to acceptability, communication, and evaluation of the most effective ways to measure certain behaviors in the context of microbicide trials. 

Additional areas for future consideration include: 

		Cohort studies of children born to HIV-infected mothers who participate in HIV prevention interventions (e.g., HIVNET 012; PETRA) to assess non-biomedical, long-term social and behavioral outcomes
		Evaluation of the effectiveness of different family planning counseling strategies for HIV-infected women.
		Evaluation of various communication strategies regarding 'partially effective' biomedical interventions, such as microbicides and HIV vaccines, for participants in phase III trials and the larger population once these products are widely available.

The following underlying principles should be considered when planning all future research/programs: 

		Long-term/sustained behavior change must be the goal of interventions.
		Influence on community norms rather than individuals should be the focus.
		Behavioral interventions must be integrated into existing prevention programs and biomedical interventions.

David Celentano, Chair, Johns Hopkins UniversityD
Danielle Haley, Family Health International

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