Summary

In 2004, the Prevention Leadership Group (PLG) of the HIV Prevention Trials Network (HPTN) recommended that the Network strive to improve the standard of care that exists at HPTN sites and to document efforts, activities, and accomplishments towards this end. The PLG charged the Ethics Working Group to develop, with community input, a survey to document alliances already in place and to assess what the HPTN is doing at each site to provide or facilitate HIV-related care and, ultimately, other health-related care partnerships. The Partnering for Care project was undertaken to meet this objective. A description of the methods and overall findings from the project can be found in Part I of the report, and are summarized below as well. 

A brief email survey was sent to Principle Investigators and study coordinators at all HPTN sites in summer 2004 (33 sites). Respondents were asked whether their sites had partnerships in place to provide care for research participants (yes or no). A second email survey was conducted between June and December, 2005. “No” responders to Survey 1 were asked to complete an abbreviated survey focusing on health care referral options and regulatory requirements or policies regarding provision of care. Survey 1 “Yes” responders were asked the same questions plus others describing their partnerships. Based on responses received and in consultation with investigators responding to Survey 2, seven sites were selected for in-depth case study analysis:

		UNC Project, Tidziwe Centre, Lilongwe, Malawi
		MU-JHU Research House, Kampala, Uganda
		UZ-UCSF Collaborative Research Programme, Harare, Zimbabwe
		MRC, Durban, South Africa
		NARI, Pune, India
		FIOCRUZ, Rio de Janeiro, Brazil
		University of Pennsylvania, Philadelphia, PA, USA

From March through May 2006, FHI social scientists working together with local HPTN collabora­tors at the seven selected sites visited study clinics, referral sites, and the communities in which research participants lived and worked. Through observations and conversations with study site staff, referral site staff, and community advisory board (CAB) members, they 1) chronicled the efforts of each HPTN site in developing referral systems with healthcare partners, 2) explored how partner­ships between the study and referral sites are maintained, and 3) considered the strengths and challenges of developing and maintaining healthcare referral partnerships that benefit research participants.

There are essentially two ways that researchers can meet the health needs of research participants: through direct provision of care or through referrals to hospitals, clinics, or other organizations. All HPTN research includes some combination of direct care and referrals. Several key factors were identified through the case studies that contribute to the balance between direct care and health care referrals at a research site, as well as the overall quality of the health care that could be made available to research participants.

		Public health system constraints were a pervasive influence at all HPTN sites. The syndemic nature of HIV means that people who participate in HIV prevention research often have multiple treatment, care, and service needs. At all sites, clinics that served the neediest members of society had long lines, waiting lists, and restrictive rules about who can access what care and where. Attempts to improve health care for research participants without consideration of the larger health system constraints could have unintended negative consequences.
		Local community values, attitudes and priorities were a similarly pervasive influence on HPTN site responses. Since the beginning of the epidemic, HIV has highlighted the importance of cultural sensitivity and respect for community in the way public health responds. This is no less true for the context of HIV prevention research than for the provision of prevention services, treatment, and care more broadly.
		A public health attitude on the part of research leadership and staff was important for fostering pro-active efforts to address health care challenges. Elements of this attitude included recognition that HIV prevention research is conducted in a larger context of health care delivery and public health policy, that the research team may identify health care needs that exceed local response capacity, and that researchers must therefore be prepared to respond to health needs that go beyond what is necessary to meet scientific goals. A public health attitude also meant that research teams understood the limits of what they could accomplish on their own and hence the importance of partnering with other public health stakeholders as they sought to meet health care needs identified in the course of research.
		Referral follow-up procedures were important for identifying barriers to care, including lack of transportation, program enrollment fees or other costs, long queues, understaffing, and drug stock-outs. Once barriers were identified, steps could be taken to address them. Considerable effort and resources were often needed to do such follow-up effectively and to address the problems identified.
		Physical proximity of the research site to the referral clinics, hospitals, and service providers made it easier to address referral challenges as well as to build mutually beneficial partnerships with referral sites.
		The type and extent of capacity building efforts reflected the range of local needs as well as the type of research, the nature of the research organization, and the resources available. At times, both community stakeholders and research staff needed to work through false assumptions and misunderstandings about each other’s strengths and weaknesses before effective capacity building plans could be put in place.
		Those research organizations that conducted studies where people living with HIV/AIDS are enrolled in research, such as PMTCT trials, tended to have in-house capacity to provide treatment and care directly to participants. Conversely, those organizations that enrolled primarily or only uninfected persons tended to have much more limited clinical capacity and were therefore more reliant on meeting participant needs through referrals.
		Community engagement efforts undertaken by the research team enriched and deepened their understanding of the lives of research participants. They gained a clearer sense of the role of their research in assuring the conditions of health for the community as a whole. They also became aware of opportunities where they could substantively contribute to improving those conditions.
		Partnership-building efforts undertaken by the research team were crucial to facilitating health care referrals. Some partnerships grew organically from personal contacts among research staff and word of mouth among community-based professionals working in similar areas. Others emerged as specific needs were identified among research participants or related research groups such as CABs. Sometimes a fortuitous event brought people together to fill a need.

The detailed case studies in Part II of this report demonstrate the full complexity of the challenges faced by HPTN sites; neither problems nor solutions are simple. Ultimately each site must decide how far down the list of health needs the research team can go without depleting the time, resources, and energy needed to do the research. The dedication, creativity, and initiative of the research teams and community members are a source of inspiration in this regard. Hopefully, this report will help to generate additional resources to support their efforts as well as to address the broader health care access and delivery problems that make such efforts necessary.