Rolling out new biomedical HIV prevention tools: what can be learned from Avahan, the India AIDS initiative?

Additional keywords: interventions, key populations, peer outreach, programs, syphilis.

Recent advances in biomedical HIV prevention research, such as pre-exposure prophylaxis (PrEP) and antiretroviral-based treatment, have brought new tools to HIV prevention.^1,2 However, they also pose significant challenges, including understanding the utility and limitations of these advances in the context of existing programs and prevention tools, the strategic allocation of scarce resources and translating findings into effective, scaled programs.^1–3 Programs should (1) address the need for adherence by the individual to the product and a high degree of interaction with the health system; and (2) for optimal cost-effectiveness, focus on subpopulations at higher risk such as serodiscordant couples or key populations (KPs): female sex workers (FSWs), men who have sex with men (MSM), transgender persons (TGs) and persons who inject drugs (PWID).^4–7 PrEP implementation, which currently entails quarterly HIV testing, will require regular contact between healthy adults and the health system, with regular testing for HIV and monitoring for adverse effects. Accomplishing the behaviour change in both providers and PrEP recipients for this regular follow-up will be a challenge, one magnified by the current limited access of KPs to health services in many settings. This poor coverage is due to many factors, including inadequate HIV program budgets, a disproportionate focus on scaling up AIDS treatment, the constrained legal and policy environment for these populations, lack of leadership, limited epidemiologic data, violence, stigma and discrimination.^8–11 Nonetheless, unless programs develop the ability to deliver HIV preventive services to KPs at scale and with high coverage, the potential impact of any prevention modality is likely to be minimal.

Given that scale and coverage are critical to any intervention success, in this paper, we briefly discuss the intervention approaches used to achieve scale, high coverage and impact by Avahan, an HIV prevention program targeting KPs in India. We then provide examples of how this basic prevention infrastructure was used to deliver sexually transmissible infection (STI) services and expand service scope in biobehavioural interventions and structural interventions, both within the project and through referral. Finally, through these examples, we discuss some aspects of Avahan’s implementation experience that might be applicable to other settings and other biobehavioural interventions.

The first phase of Avahan (2003–2009) was intended to rapidly scale up known HIV prevention interventions with an incorporated community mobilisation approach in the six states of India with the highest HIV prevalence at the time, aiming to achieve >80% coverage of KPs (FSWs, high-risk MSM and TGs, and PWID) and bridge groups (men at risk) collectively with other funders, principally the Government of India.^12,13 Each funder focussed on distinct geographic areas in order to maximise KP coverage and avoid redundancy, though there were some differences in the intervention definitions, delivery and management processes. Avahan’s multicomponent prevention package addressed both proximal and distal determinants of risk (Fig. 1). In the four southern states where Avahan worked, programs for KPs were implemented in 70 districts. KP programs were managed and technically supported by six lead implementing partners who subgranted to 116 local nongovernment organisations (NGOs).¹⁴ By the end of Phase 1, these local NGOs were implementing HIV prevention interventions for ~220 000 FSWs and 80 000 high-risk MSM and TGs.¹⁴ Three years after the project started, >75% of the eventual total of STI clinics and drop-in centres (safe spaces) had been established, and ~85% of the final total of frontline peer outreach workers were trained and active. After 5 years, the project was consistently meeting, on a monthly basis, over 85% of mapped and enumerated FSWs, and 65% of high-risk MSM and TGs.¹⁴ Two modelling assessments using different methodologies estimated that the Avahan intervention averted a significant number of HIV infections. Pickles and colleagues estimated 202 000 infections were averted in the first 4 years and 606 000 infections over 10 years.¹⁵ Ng and colleagues estimated that 100 200 infections were averted over 5 years.¹⁶

Fig. 1.  Avahan project logic model. Sexual health services were scaled up in conjunction with the government of India and others to ensure saturated coverage (over 80% of estimated target populations) in all 83 districts where Avahan worked across India. KP, key population; STI, sexually transmissible infection; CBG, community-based group.

In 2003, India had several characteristics that facilitated and informed Avahan’s scale-up. From a policy and strategy perspective, under the National AIDS Control Program II (2000–2006), KPs were a recognised programming priority, and the government and other donors supported a package of well articulated targeted interventions, although the resource commitment was relatively small and there were significant implementation issues related to low coverage, diffuse target group focus and service quality.^17,18 From a strategic information perspective, the government supported routine sentinel site HIV surveillance in KP interventions, starting in 1998 for FSWs and PWID, and in 2000 for MSM; established nationwide and state-level behavioural surveillance surveys in 2001, which included FSWs, clients of FSWs, MSM and PWID; and conducted a large-scale, high-level FSW size estimation exercise during National AIDS Control Program II.^19–21 From a capacity perspective, HIV prevention programming for FSWs and their clients had been funded for several years before 2003 in the four southern states where Avahan worked.¹⁷ As a result, both the State AIDS Control Societies and several NGOs in these states were experienced in HIV prevention programming and had working relationships on implementation issues such as funding, reporting, condom provision and health referrals. MSM and TG programming in these states was more recent and more limited.¹⁷ From a community mobilisation perspective, India has an extensive history of successful participatory development approaches, ranging from longstanding production cooperatives to large self-help group movements.²² The Sonagachi project in Kolkata, West Bengal, is a globally recognised model of a community-led FSW intervention resulting in both HIV risk reduction and improved social outcomes.²³

HIV prevention interventions among FSWs, MSM and TGs, however, were hampered by legal issues, pervasive stigma and discrimination, including from health providers and by social stratification. FSWs are of low social status, tend to have low levels of literacy and limited economic options, are often the sole supporters of children, and face violence from pimps, madams, partners and clients, as well as extortion or violence from the police.^24,25 Although the commercial exchange of sex between consenting heterosexual adults is not illegal in India, police extort and arrest FSWs, invoking the Immoral Trafficking Prevention Act or, more frequently, ‘public nuisance’ laws.²⁵ The context for MSM and TG programming had similar constraints. The Indian Penal Code (Section 377) makes sexual relations between men a criminal offence. There is widespread social intolerance of MSM and TGs, who experience violence from police, family and society.²⁶ Most MSM do not self-identify as such and, because of cultural pressure for marriage, a large percentage are married and interact with both MSM and heterosexual sexual networks.²⁷

Working in a setting with the many enablers described above and with adequate funding, Avahan was able to scale up KP programs through three broad design approaches. First, to support community ownership and social norm change, a progressively participatory approach was implemented whereby KPs were encouraged and capacitated to shape, refine and implement the program.²² Second, to support management and performance measurement, a common minimum program was developed to set minimum standards, which were periodically and iteratively improved and expanded. Routine data collection systems were established to aggregate and consolidate indicators at every level, from the frontline workers through to KP–program contact points to district, stage and central levels. This enabled frontline workers and NGOs to monitor their own performance, and enabled foundation staff and lead partners to drill down from national to district levels to NGO level to analyse comparative performance. Supervision systems were built that required periodic, scheduled meetings to review the data at every level from frontline workers through to various levels of NGO staff to foundation officers (Table 1).^13,28,29 Third, to ensure geographic scale and coverage, there was a clear staged focus where the emphasis was on simultaneous geographic roll-out by (a) first creating a physical footprint with (b) a parallel focus on iterative service quality improvement and then (c) layering of additional services over time (Table 2).²⁸

Table 1.  Avahan’s organisation for supervision and capacity-building
STI, sexually transmissible infection; TB, tuberculosis; NGO, nongovernmental organisation; CMP, common minimum program; KP, key population; FSW, female sex worker; MSM, men who have sex with men; TGs, transgender people

Table 2.  Stages of Avahan Phase 1 scale-up: goals and activities, monitoring areas and associated indicators
DIC, drop-in centres; KP, key population; STI, sexually transmissible infection; NGO, nongovernment organisation; TB, tuberculosis

Although these implementation approaches represent, for the most part, well articulated management techniques, as applied in Avahan, they comprehensively addressed criteria for management excellence, as outlined in the Baldrige framework. Their rigorous application was an important factor for the scale-up of the program.³⁰ Of note, KP peer outreach workers were compensated and made responsible for outreach service delivery and outreach management. Microplanning tools were developed for their use, coupled with clear targets, and they were given authority and responsibility for meeting the targets, resulting in a marked increase in the number of KPs contacted monthly by KP peer outreach workers, a narrowing in the condom distribution gap (the difference between the estimated number of condoms needed by sex workers, based on reported client numbers, and the number of condoms distributed) and increased clinic utilisation.^22,31–34

After establishing STI service delivery across the program, this existing implementation infrastructure was used to scale syphilis screening and treatment, strengthen referral for HIV testing and counselling, and align services with government guidelines. This experience may offer potential lessons for the implementation of new biobehavioural tools and is discussed below. (Not discussed below is the experience in utilising this infrastructure to implement community-based verbal screening for tuberculosis symptoms and linkage with the national tuberculosis program to identify active cases.³⁵)

STI management was an essential component of the Avahan prevention package (Fig. 1). In order to make STI services as accessible as possible with cost considerations in mind, four main delivery models were used across the project, depending on the density of the KPs. These included (1) static clinics that were colocated with the NGOs and, for the most part, staffed and managed by them; (2) satellite and mobile clinics, and health camps, again staffed and managed by the NGOs; (3) preferred providers (private providers contracted and trained by the NGOs to provide services); and (4) government clinics, often supported by local NGOs with supplies or with staff during specific hours.³⁶ The models, informed with input from the community, often had flexible timings to meet community needs, such as health camps in the evenings and during festivals, preferred providers who worked evenings, and services in bar-based settings just before work hours began. ‘Project-owned’ clinics (Types 1 and 2 above) constituted most of services and were places where the quality of services and the quality of reporting data could be most easily ensured.

Syphilis screening and management were part of the initial standardised guidelines and algorithms specified in the STI Clinic Operational Guidelines and Standards for STI clinical services in Avahan clinics.³⁷ However, in many of the project-owned clinics, syphilis screening was not initiated because the infrastructure requirements and staff skills for drawing blood, laboratory testing, quality assurance and control, universal precautions and laboratory commodity management were significantly beyond the expertise and experience of most implementing NGOs. In addition, much of the management attention at the beginning of the project was focussed on project start-up, including coordination with outreach teams, improving the quality of syndrome management and increasing clinic utilisation. Where syphilis screening was started, the initial strategy was to offer onsite or offsite screening with onsite phlebotomy using nontreponemal tests such as rapid plasma reagin (RPR), with confirmation of positive results by treponemal tests at an offsite laboratory. However, the operational complexities, particularly for offsite screening, the long waiting period for results and fear of venipuncture by KPs resulted in low uptake of syphilis screening and significant losses in follow-up where testing was offered.^38,39

In 2007, after the results of the first round of the cross-sectional biobehavioural evaluation survey indicated a high prevalence of syphilis among KPs, there was a project-wide effort to expand syphilis screening and treatment across the entire program.¹⁹ Communication materials were developed that described the process and benefits of syphilis testing, and differentiated it from HIV testing. Using the supervision and capacity-building infrastructure outlined in Table 1, the KP peer outreach workers were trained to communicate about syphilis testing and treatment. The KPs were motivated for syphilis screening by the peer outreach workers and community volunteers during routine outreach activities and by healthcare providers during clinic visits. Healthcare providers were also trained in management of anaphylactic reactions resulting from use of injectable penicillin for treatment of syphilis, a major concern in the medical community in India. To address the operational complexities of drawing blood and offsite testing, a rapid treponemal, point-of-care (POC) syphilis test was introduced at sites where RPR testing was not available or feasible. Algorithms were developed for use of this POC test, as the initial screening method; for those testing positive, offsite RPR testing was recommended for prognostic titres and future screening. A study showed that the rates of syphilis screening increased (from 14.3% to 63.1% per quarter) after introduction of POC at FSW sites in Mumbai, a large city.³⁹ Based on routine monitoring data, however, despite the efforts of the program, screening coverage remained low at 22%. There was under-reporting of syphilis testing data from two sources: outreach efforts through heath camps and the inability to link syphilis data records to clinic records through the unique ID when merging the record. This data loss could have been minimised through a better designed and standardised use protocol at the beginning of the program and, in this particular case, by ensuring that syphilis screening data were recorded in the clinical records rather than being a separate report.³⁸

External quality assurance for onsite RPR tests was established through tie-ups with referral laboratories, with 100% of positive and 5–10% of negative samples retested either on an ongoing basis or periodically. External quality assurance for POC tests was conducted at select sites in three states by retesting intravenous blood samples at reference laboratories and by proficiency panel testing. Initial results showed poor concordance between POC testing and reference laboratory results. Investigations revealed that clinic staff were not following procedures correctly; after a refresher training, repeat proficiency panel testing improved significantly (internal project documents). POC testing greatly improved access to laboratory results for KPs, and external quality assurance was a critical component of training and supportive supervision of health personnel performing these tests. However, ensuring the quality of testing was a significant problem, especially in towns and remote sites lacking a local accredited reference laboratory, or which had difficulty transporting samples or managing costs.

STI management interventions and referral support to government facilities for HIV counselling, testing and treatment were interventions initiated from the beginning of the project. In 2007 primary HIV care services were introduced at the Avahan clinics, with new guidelines and additional components to the common minimum program. Clinic staff were trained to provide chemoprophylaxis and care for opportunistic infections, and counselling for positive prevention using the capacity building oversight structure described for STIs in Table 1.^40,41 In order to increase uptake of HIV testing and counselling, KPs were encouraged to be tested for HIV and were accompanied to HIV testing and counselling centres if requested. NGOs were charged with sensitising local HIV testing and counselling centres to special issues related to KPs and monitoring them for this aspect of quality. Data from the cross-sectional bio-behavioural surveys done in 2005–2007 (Round I) and 2009–2010 (Round II) showed that for FSWs overall in the four southern states, ever having had an HIV test increased from 35% to 73% and having been tested in the last year increased from 25% to 60%. For high-risk MSM and TGs in three southern states (Karnataka excluded; Round II was performed in 2012) ever having an HIV test increased from 30% to 80% and being tested in the last year increased from 20% to 64%.⁴²

In 2009, in preparation for the eventual transition of the Avahan program to government funding, Avahan programs aligned with National AIDS Control Organisation guidelines and the explicit targets for KP interventions and antiretroviral therapy (ART) scale-up. As a result, HIV testing and counselling efforts expanded to meet the goal of twice-yearly referrals to HIV testing centres, linked, as necessary, to facilities for treatment, care and support.^21,43 Activities to increase KP access to HIV testing, treatment, care, and support were incorporated into the common minimum program, and Avahan interventions partnered with government ART programs. Referral metrics were incorporated into KP peer outreach worker microplanning tools, and providers in STI clinics offered referrals for HIV. To address the numerous constraints in accessing HIV testing and treatment (stigma, mismatch between KP availability and timings of ART services, limited awareness of the value of HIV testing and ART availability, disclosure, the importance of ensuring there was no coercion, and support structures and groups for HIV-positive KPs), several initiatives were established. Consenting HIV-positive KPs who disclosed their status to the counsellor and KP peer outreach worker received an accompanied referral; educational efforts were undertaken by KP peer outreach workers and clinic staff to explain the rationale for testing and details of ART centre procedures. Avahan Phase 2 data show that the total number of HIV tests in KPs increased from 62 546 in 2009 to 247 633 in 2012 (the data are not for individuals, as people were referred twice yearly).

As part of transitioning the Avahan project to the government of India and aligning the program components with the government, funding for most project-owned STI services was stopped and clients were transitioned to preferred providers or government clinics.⁴⁴ To manage this transition of STI clinical services to government clinics, several activities occurred: (1) KPs were encouraged to access services at these facilities by KP peer outreach workers who cited the advantages of having various services (STI consultation, syphilis screening, HIV testing and counselling, tuberculosis screening and treatment, and other health services) offered at a single location; (2) ‘Know your doctor’ campaigns (meetings between community members and public-sector healthcare providers) were conducted; (3) several public-sector campaigns for KPs helped increase their confidence about using government services; (4) through capacity-building workshops and interactions with the community at the NGO office, public-sector healthcare providers were sensitised to the needs of KPs, and the requirement for providing nonstigmatising services and maintaining privacy and confidentiality,; (5) a community member was placed at some large government hospitals to help KPs access the requisite services at the hospital; and (6) the NGO assisted government sites that provided routine STI check-ups for KPs on predetermined days, by supplying colour-coded prepackaged STI treatment kits used in the project, and by placing a nurse or counsellor to assist the public sector physician. From a structural perspective, under National AIDS Control Program III KP community members were ex officio members of the District AIDS Prevention Control Unit, where sharing the KP community’s experiences of accessing public sector health facilities was a routine agenda item at the monthly meetings.⁴⁵ Monitoring data for the 24 months after transition showed that clinic attendance rates appeared stable.⁴⁴

As noted earlier, KPs often live and work in settings with widespread stigma, pervasive violence and limited individual or collective agency (the belief that they can take decisions and act for themselves). In 2006, a community-led crisis response system was implemented to address the immediate need to respond to extortion, harassment and violence against KPs by police and clients, including legal literacy training for KPs and police, and improved dialogue with police.⁴⁶ This experience strengthened the collective power of KPs in the program and led to other structural interventions whereby communities gained government ID cards, and sought to address discrimination, to gain access for their children to schools and to improve norms in their work environment.^25,47–49

As part of the Avahan evaluation, multiple rounds of cross-sectional surveys were conducted in selected districts among KPs to provide data on the outcomes of the program.⁵⁰ Given the sensitivities of KPs, especially about collection of data pertaining to stigmatised sexual behaviours and biological samples, meaningful community engagement was embedded in survey implementation to ensure that targeted communities were encouraged to voice their concerns, and processes were developed to minimise harm and address power dynamics. These activities built upon and strengthened the community committee structure established for drop-in centres and clinics, and sought to increase the agency of the KP communities. Besides helping to build trust, these community preparation activities increased the communities’ understanding of the surveys, created a venue to raise questions and concerns, facilitated dialogue within the KP community and between community and survey teams, and helped the dissemination of results by creating community ownership of the findings for improving programs.

Key lessons that would be applicable to KPs programs elsewhere include the following:

1. Given the importance of geographic scale and high coverage for impact, the implementation gap for prevention programs for KPs is a major shortcoming of the global response to HIV.⁵¹ Therefore, it is important that the implementation of new prevention tools does not detract or undermine other elements of ongoing prevention and does not divert prevention resources from KP sites that have no prevention activities at all.⁵²

2. It is essential to build and foster a mobilised community and establish community mechanisms that can work with the program to solve problems; provide critical inputs pertaining to strengths and challenges with access and utilisation, and the community-friendliness of these interventions; disseminate accurate information and correct misconceptions; support the norm of adherence and regular testing; help deliver services; and organise to address stigma, discrimination and violence. All of the Avahan examples above relied on a strong community to both inform and scale up the intervention. An engaged, mobilised community was essential to Avahan’s success and to the layering on of additional services and program changes over time. The utilisation of government services by the community after the transition of Avahan was ideal but would probably not have been possible without a strong community with enough experience to know what to expect in terms of service quality, and enough agency to monitor and report perceived deficiencies in quality to authorities. In the first 2 years of Avahan, from lead partners down, community mobilisation and enabling environment costs represented 14.9% of total economic costs.⁵³

3. Having a capacity-building, supervision and data collection system that is flexible enough to absorb new lessons, changes and additions to an initial core definition of the program allows the program to adapt. The supervision and review system should be able identify local innovations, and the program should foster interactions across the partners to ensure that useful local innovations and adaptations to a changing environment are shared widely and, if sound, are adopted program-wide.

4. Building in extra time and support to organisations being asked to implement services that are not core to their business (Table 3) maximises the chances for success. For example, in Avahan, most contracted NGOs did not have a history of providing clinical services or laboratory tests; as a result, establishing quality services took time and effort, as illustrated by the syphilis screening experience. On the other hand, close linkage between the NGO clinical service and the outreach services, which is an NGO strength, allowed for direct community input into the acceptability and accessibility of services, and for weekly planning to identify individuals who had not come to services, ensuring high coverage.

Table 3.  Biobehavioural interventions in nongovernment organisation (NGO) or community-based organisation (CBO) services, and clinic-based service
Illustrative activities are core to the service delivery model of the organisation; services that are not necessarily core (‘reach activities’) require additional support to ensure quality. KP, key population; QA, quality assurance; QC, quality control; ARV, antiretroviral

More than 30 years after HIV was first identified, it still continues to occupy centre stage in many countries. New biobehavioural prevention tools such as PrEP offer promise but to have an impact, they require high coverage with sustained, high-quality engagement between health services and select subpopulations. Some of the practices instituted in programs such as Avahan can be relevant in effectively rolling out these new biobehavioural interventions in KPs.