Adolescents and young adults (AYA, 10–24 years old) represent over a quarter of the world's population  and 90% live in low and middle-income countries (LMICs). The Joint United Nations Programme on HIV/AIDS (UNAIDS) estimated 3.9 million people aged 15–24 years are living with HIV infection . Each day, approximately 1600 AYA acquire HIV infection and approximately 144 AYA die from AIDS-related illness [2,3]. The increasing number of LMIC AYA coming of age in the next 20 years underlines the urgency of HIV control in this demographic group [3,4]. HIV remains a major cause of death in AYA in LMICs [5,6]. In addition, AYA lives are substantially impacted by HIV infection, regardless of setting [7–11]. Unique cognitive and developmental issues among AYA not only threaten the capacity for them to prevent HIV but also their ability to stay healthy and thrive if they are living with HIV [7,8,10,12].
Despite the importance of AYA HIV research in LMICs, many AYA HIV studies only focus on upper middle-income and high-income countries [4,7,9–11,13]. The United States National Institutes of Health (NIH) has noted the poor implementation of evidence-based interventions in LMICs . More rigorous AYA HIV implementation research is needed to understand the HIV prevention and care continuum in diverse LMICs [13,15,16]. LMICs often face substantial practical, logistical, and ethical problems related to AYA HIV research. For example, the lack of legal protections for minors in many countries introduces risks associated with conducting research studies . However, there are also unique opportunities for AYA HIV research in LMICs. For example, interventions that are developed in or adapted for resource-constrained settings may be more scalable in LMICs. A better understanding of the AYA HIV service pathways can inform interventions to optimize HIV prevention and care [18,19].
To address these gaps, the PATC3H consortium was launched in 2018 by the NICHD. The overarching goal of the PATC3H consortium is to coordinate global health research to reduce HIV incidence and related health disparities among AYA in LMICs (Fig. 1). PATC3H seeks to implement and evaluate interventions that can achieve long-term viral suppression among AYA living with HIV (ALHIV) and reduce onward transmission and acquisition of HIV among at-risk AYA. The first round of sponsored research projects supported eight research projects, with fieldwork in Brazil, Kenya, Mozambique, Nigeria, South Africa, Uganda, and Zambia. The request for proposals required a novel milestone-based approach that required completion of prespecified milestones in order to transition to the next phase of NIH support. The initial NIH request for grant proposals noted that receipt of initial phase 1 (UG3 phase) support did not guarantee subsequent phase 2 (UH3 phase) support. Milestone transition required sustainability plans to include health stakeholder (national health ministry, civil society, education) engagement and achievement of prespecified goals to demonstrate efficacy and feasibility of research protocols. Health engagement and protocol development focused on planning for randomized controlled trials and program implementation. Many PATC3H studies required substantial AYA engagement focused on preparing for protocol implementation. We defined engagement as a multifaceted process of being involved in the research process across the entire life of the research study . This manuscript describes the PATC3H consortium, transition milestones, and youth engagement strategies.
This analysis presents programmatic data from each of the eight PATC3H studies. Organizational data about transition milestones were obtained from NICHD, with written permission from each of the PATC3H research teams.
Principal investigators also completed a short survey (Supplemental Data 1, https://links.lww.com/QAD/C262) of their study's transition milestones and AYA engagement according to a modified Hart's ladder designation . The survey was part of program evaluation and exempt from institutional review board approval. Levels of engagement included minimal (e.g. AYA joining a youth advisory board), moderate (e.g. AYA decisions changing the timing of follow-up), and substantial (e.g. AYA creating a major part of the intervention). Levels of engagement were not mutually exclusive. We asked about how each of these levels of engagement related to study design, participant recruitment, participant retention, and dissemination of findings. We also asked about involving AYA as paid members of the research team and other ways to drive engagement.
Questionnaire items on milestones assessed what was done differently in the initial phase of the grant because of the milestone transitions compared with grants that did not have milestones. We also requested complete transition milestones. Given that the COVID-19 pandemic coincided with the second year of the grant, researchers were provided flexibility in adapting milestones. Data from the questionnaire was used to clarify AYA engagement and transition milestones.
Table 1 outlines the characteristics of the eight studies [22–35]. All studies proposed pilot and preparatory research during the initial 2 years, followed by a randomized controlled trial in the subsequent 3 years of the project. Three studies focused on HIV prevention, three focused on HIV treatment, and two studies combined HIV prevention and treatment. Studies were conducted in Mozambique (Combination intervention strategy to improve health outcomes for adolescents, CombinADO), Kenya (Data-informed stepped care, DiSC; SEARCH-Youth), Uganda (SEARCH-Youth), Nigeria (Intensive Combination Approach to Rollback the Epidemic, iCARE; Innovative Tools to Expand Youth-Friendly HIV Self-testing, I-TEST), South Africa (Informed Motivated and Responsible about AIDS, IMARA; CombinADO), Zambia (Support for HIV Integrated Education, Linkages to care, and destigmatization with Integrated Wellness Center; SHIELD & IWC), and Brazil (Brilhar e Transcender, BeT). A data harmonization working group facilitated shared survey items, domains, implementation data, and costing approaches across studies. The next sections describe study summaries, theoretical frameworks, HIV prevention, HIV care, HIV service delivery and implementation science, transition milestones, and community/AYA engagement.
Table 1 -
Overview of studies included in the PATC3
||Initial 2-year phase (UG3)
||Subsequent 3-year phase (UH3)
||Social Cognitive Theory
||Develop, implement and measure a community-informed antistigma social marketing campaign; pilot an adapted evidence-based systems navigation intervention using peer delivery and mHealth in trans-affirming health clinics
||A single arm Hybrid Type 1 implementation science study with a pre design/post design and an external comparator
||HIV testing (pilot phase only), PrEP uptake and adherence, linkage to HIV care
||Prevention and treatment
||Adolescents living with HIV
||Develop and pilot intervention strategy that includes; peer navigation and support, adolescent friendly services, and health communication messaging
||A clinic-level cluster-randomized controlled trial (RCT)
||Retention in HIV care, ART adherence, viral load suppression, cost-effectiveness
||Adolescents living with HIV
||Stages of change
||Clinic-based prospective cohort and their care givers-surveys and abstraction of medical records to develop clinical prediction tool
||Feasibility and acceptability, retention in HIV care, viral load suppression, ART adherence, health services efficiencies (HCW workload, client satisfaction, wait time)
||YMSM (prevention); Adolescents and young adults living with HIV (treatment)
||Social cognitive theory, youth empowerment, peer support
||Develop digital interventions to enhance: (a) HIV testing and linkage; and (b) HIV care outcomestwo pilot interventions
||Stepped wedge trial with 600 participants
||HIV testing, linkage to care, retention in HIV care, ART adherence, viral load suppression
||Prevention and Treatment
|IMARA, South Africa
||Adolescent girls and young women and female caregivers
||Individual, social and structural drivers of HIV risk
||ADAPT IMARA for adolescent girls and young women and their female care givers using the ADAPT-ITT model; Establish feasibility and acceptability
||RCT with 525 adolescent girls and caregivers and their female caregivers
||STI incidence, HIV incidence, PrEP uptake, HTC uptake, cost-effectiveness, sexual behaviors
||Youth Participatory Action Research
||Use open challenges and apprenticeship training to develop new HIV self-testing services and evaluate their effectivenessAs a pilot and via discrete choice experiments
||Stepped wedge cluster RCT with 1440 at-risk HIV-negative youth
||HIV testing with digital verification (USSD or photo-verification), gonorrhea/chlamydia/syphilis/hepatitis testing, PrEP initiation, 100% condom use, youth engagement
|SEARCH-Youth, Uganda and Kenya
||Adolescents living with HIV
||Implement youth-led HIV testing and linkage programs using a community-based participatory research (CBPR) to reach AYAH who are undiagnosed or are not engaged in care
||Cluster RCT of 1400
||Retention in HIV care, viral load suppression,Mechanisms of action and barriers and facilitators of intervention (community, clinic, organization, provider and patient levels), incremental costs and gains of intervention (costs, costs averted, disability-adjusted life years gained)
|SHIELD & IWC, Zambia
||Adolescent girls and young women
||Engage stakeholders by establishing community and youth advisory boards, conduct formative research, adapt modules, conduct pilot study to evaluate implementation processes. DCEs
||Cluster RCT design with 600 HIV-negative and 525 HIV+ girls
||HIV testing, retention in HIV care, viral load suppression, sustainability and cost-effectiveness
||Prevention and treatment
ART, antiretroviral therapy; AYA, adolescents and young adults; DCE, discrete choice experiment; HCW, healthcare worker; PrEP, pre-exposure prophylaxis; RCT, randomized clinical trial.
Summary of studies
Two studies focused on the HIV prevention continuum (IMARA, and ITEST) and three studies focused on the HIV care continuum (CombinADO, DISC, and SEARCH-Youth). Three studies focused on the prevention and care continuums (iCARE, SHIELD & IWC, and BeT). Two studies (BeT and iCARE) specifically focused on key youth populations, with BeT focusing on the needs of AYA transwomen in Brazil, whereas iCARE addressed the needs of young MSM in Nigeria. Four studies (Combinado, DiSC, SHIELD & IWC, ITEST) included AYA groups aged 10–14 years and all studies included 15–19-year-old groups. Five studies (BeT, iCARE, ITEST, DiSC, SEARCH-Youth, SHIELD & IWC) included young adults aged 20–24 years old.
The eight studies employed various theoretical approaches in the design of interventions focused on the prevention of new HIV infections among youth vulnerable to HIV infection, and the identification of, linkage to and retention in care of, and long-term viral suppression among ALHIV. Three studies (CombinaADO, IMARA, and SHIELD & IWC) used socioecological models to emphasize the reciprocal interactions between individual, social, cultural, and environmental systems that influence drivers of HIV risk or health-seeking behaviors among AYA. Another study (DiSC) applied an eco-developmental theory for adolescent care-seeking to a stepped care service delivery model grounded in the Stages of Change theory. The goal is to use stepped care to appropriately match AYA with a level of clinical support that is relevant to their needs. Pilot data were used to develop risk scores to identify youth at risk for loss to care, which were then incorporated in tiers of the stepped care model. Two studies (BeT and iCARE) used tools, such as peer delivery (BeT) and peer navigation (iCARE) to improve HIV testing and linkage among key populations. One study (BeT) used peer delivery to enhance PrEP uptake among key populations. Four studies (BeT, iCARE, ITEST, and SEARCH-Youth) used mobile health technologies (mHealth) as a core intervention component, with two focused on using short messaging services (CombinADO and iCARE) to communicate messages to their participants. BeT used digital tools, such as WhatsApp to navigate and link participants to HIV testing. The SEARCH-Youth study used digital tools to link ALHIV to providers and for provider–provider consultation on challenging cases. ITEST used crowdsourcing as an approach to enhance youth engagement, develop creative youth-friendly services, and spur innovation. Crowdsourcing has a group of individuals who solve a problem and then share with the public . Four studies used participatory approaches in the design of their studies. CombinADO used human-centered design, a systematic approach to problem solving that focuses on the end-user's desires and needs. ITEST used youth participatory action research, which provides young people with the opportunities to design and implement youth-friendly HIV self-testing (HIVST) services strategies. DiSC convened stakeholder groups to iterate design of stepped care intervention, including AYA, healthcare workers, caregivers, and policymakers. Finally, SEARCH-Youth used a community-based participatory research approach to identify barriers to testing and treatment among ALHIV.
With HIV infections occurring at high rates among adolescent and young people, five of the studies (BeT, iCARE, IMARA, ITEST, SHIELD & IWC) explored HIV testing behaviors among AYA. One study (BeT) explored HIV testing frequency and PrEP use among young trans women in Brazil, using mHealth tools for peer-delivered system navigation to increase the frequency of HIV testing and engagement in PrEP. Similarly, three studies (iCARE, IMARA, and SHIELD & IWC) evaluated the acceptability and feasibility of using manualized interventions to increase HIV testing uptake. Finally, with evidence and recommendation on using HIV self-testing as a way to reach young people who may not otherwise test, one study (ITEST) used designathons, crowdsourcing contests, and related participatory activities to increase the uptake of HIV testing among young people in Nigeria.
Strategies to sustain high levels of adherence to antiretroviral therapy as well as viral load suppression are among the top priorities of six (BeT, CombinADO, iCARE, DiSC, SEARCH-Youth, and SHIELD & IWC) of the PATC3H studies. Given the unique influencing factors limiting adherence and viral load suppression, two studies (BeT and iCARE) used m-Health tools, including SMS text messaging to engage ALHIV in HIV care. BeT also utilized mHealth tools for systems navigation and peer-based support to engage young trans women in HIV care and promote adherence. A stepped care approach that organizes services according to need was used by one study (DiSC) to enhance care cascade outcomes among ALHIV in Kenya, whereas another study used life stage counseling (SEARCH-Youth) to evaluate barriers along the care continuum faced by adolescents and young adults with HIV. Finally, an integrated care delivery model was used in Zambia (SHIELD & IWC) to connect ALHIV to supportive care platforms that increase retention in care and viral load suppression.
HIV service delivery and implementation science
Reduction of health disparities among ALHIV in LMICs also requires youth-friendly services that address their needs. Enhancing service delivery across the prevention and/or care cascade was a priority across all eight studies, with the goal to better serve the needs of youth at-risk of HIV and ALHIV, while reducing unnecessary burdens on the health systems and improving participant outcomes. To achieve this, four studies (CombinADO, DiSC, iCARE, ITEST) assessed the feasibility and acceptability of their interventions. Although DiSC assessed the feasibility and acceptability of implementing a stepped care model, iCARE explored whether their strategies to improve HIV testing and linkage to care were feasible and acceptable. With the goal to decentralize HIV testing, ITEST assessed whether youth-developed HIV self-testing service strategies increased the uptake of HIV testing among at-risk youth, in addition to utilizing two verification methods (mobile phone application and USSD) to verify HIVST results. iCARE explored the potential of mobile technology to reach young people at low cost. In addition to examining the acceptability and feasibility of HIV interventions targeting young people in LMICs, the cost-effectiveness of these interventions was examined. Five studies (CombinADO, IMARA, SEARCH-Youth, ITEST SHIELD & IWC) funded as part of the PATC3H determined the within trial cost-effectiveness of specific HIV-related interventions. Although CombinADO, SEARCH-Youth, SHIELD & IWC provided insight into the cost-effectiveness of optimizing and prioritizing healthcare services for ALHIV, IMARA, and ITEST identified the most cost-efficient prevention methods for youth at-risk for HIV.
Milestones were defined by discrete benchmarks required to transition from the initial 2-year phase of the grant (UG3 phase) to the subsequent 3-year phase (UH3 phase) (Table 2). All teams met their milestones and transitioned to the UH3 phase. One example of the transition milestones from I-TEST is included as Supplemental Data 2, https://links.lww.com/QAD/C262. The most common milestones were pilot intervention data (eight of eight studies), support from national government authorities (seven of eight studies), and stakeholder advisory boards (four of eight studies). Seven studies included a milestone that the national ministry of health would provide a letter of support indicating willingness to implement the study, contingent on demonstrating efficacy. To achieve this milestone, study teams met with municipal, state, and national health stakeholders to discuss project goals and obtained feedback on study design and implementation.
Table 2 -
Summary of transition milestones (gray denotes a milestone focused on this domain; white indicates no relevant milestone).
||Letter from Ministry of Healtha
||Stakeholder advisory board
||Pilot intervention feasibility
||Pilot intervention efficacy
|SHIELD & IWC
aThis letter typically indicates willingness to implement the study and the components of the intervention provided that all other transition milestones are met.
bThis milestone included identification of study sites, training and site preparation, and related components.
Pilot intervention data was a core component of all studies’ transition milestones but there was wide variation in the methodologies and study designs. All studies reported data on participant enrollment and retention. All eight studies included quantitative measures, and six of the projects complemented this with qualitative data. Seven research studies examined within trial cost-effectiveness or related costing considerations. Two studies used discrete choice experiments to better understand AYA preferences for potential interventions.
Community and adolescents and young adults engagement
Four of the studies convened a stakeholder advisory board. In some cases, the boards were framed as community advisory boards that included members of government, public health leaders, physicians, health professionals, and AYA. Stakeholder advisory boards had a diverse range of responsibilities, including the following: reviewing intervention content and training materials; providing advice on implementation strategies within the cultural context; serving as judges, steering committee members, and participants in crowdsourcing activities; and reviewing trial protocols as part of ethical review processes.
AYA engagement was a central component of all research studies (Table 3). Six projects convened AYA advisory boards to obtain detailed feedback on study design. AYA engagement was more common among those aged 19–24 years compared with those aged 14–18 years. Several studies used these same AYA advisory boards to help with participant recruitment, retention, and dissemination. Three of the teams employed AYA as researchers and peer navigators, technology consultants, study coordinators, and research assistants. Several studies included key populations, ALHIV, and other important subgroups.
Table 3 -
Timing and extent of youth engagement in the research studies. Note that engagement strategies are not mutually exclusive.
||Dissemination of findings
|Minimal youth input – for example, AYA join a youth advisory board
||1. IMARA2. CombinADO3. SHIELD & IWC4. SEARCH-Youth5. BeT6. iTEST
||1. CombinADO2. SHIELD & IWC3. SEARCH-Youth4. BeT5. iTEST
||1. SHIELD & IWC2. SEARCH-Youth3. BeT4. iTEST
||1. CombinADOa2. SHIELD & IWC3. SEARCH-Youtha4. BeT5. iTEST
|Moderate youth engagement – for example, changing timing or frequency of follow-up visits
||1. SEARCH-Youtha2. iTEST
|Substantial youth engagement – for example, adding a new aim, intervention development
||1. IMARA2. iCARE3. CombinADO4. DiSC5. iTEST
||1. iCARE2. iTEST
||1. iCARE2. iTEST
||1. iCARE2. SEARCH-Youtha3. iTEST
AYA, adolescents and young adults.
aIndicates that youth engagement at this level is planned.
The PATC3H research consortium is an innovative approach to global health research that leverages the strengths of multidisciplinary investigators, in-country support and buy-in, and diverse methodologies and approaches to improve the science of implementation of HIV research studies in LMIC settings. Requiring plans for government and other health stakeholders within transition milestones may solidify early multisectoral support for sustainability of effective programs and broader dissemination. AYA engagement proved critical to achieving the milestones, underscoring the feasibility of involving AYA across diverse settings. This analysis highlights the strengths of a research consortium in an LMIC, provides empirical data on transition milestones, and characterizes AYA engagement across the life of the research studies.
The transition milestone approach likely ensured early engagement of health stakeholders, thereby facilitating government contributions and commitments. This early engagement is consistent with the findings of a recent systematic review that showed relatively greater stakeholder engagement in the earlier stages of HIV research studies . It also supports many tenets of implementation science whereby early stakeholder engagement and attention to the local context increase the likelihood of sustainability . This complements the larger literature on results-based financing of health research in LMIC settings . Results-based financing allows scale-up only when efficacy and related milestones are satisfied.
We observed substantial AYA engagement across the 2 years of each PATC3H study, both for prevention and treatment. This contrasts a scoping review of HIV AYA engagement, which found absent or minimal engagement in 88% of the 112 included studies . The substantial AYA engagement in consortium studies may have been related to the request for proposals, a priori milestones focused on youth inclusion, theoretical frameworks emphasizing youth participation, expanding opportunities for youth engagement, or capacity building activities to facilitate youth engagement. Most research studies convening youth advisory boards have been limited to high-income countries [40,41].
This study has implications for future LMIC programs and research and studies with transitional phases. From a program perspective, this analysis expands our understanding of key components of phased milestone-driven research projects at the NIH. The NIH has phased exploratory awards (i.e. R21 or R61 period), development awards (i.e. R33 period), and cooperative awards (i.e. UG3/UH3). One analysis of a phased NIH research consortium suggests that milestones can enhance rigor and transparency in science . The data also suggest that national government support letters as a milestone requirement may enhance early stakeholder engagement, consistent with an analysis of phased NIH awards . At the same time, sustained engagement across and beyond the life of a study is important for translating research into programs. From a research perspective, this study has implications for organizing adolescent research studies in LMICs. For example, the data from this consortium suggest that AYA can be meaningfully engaged in more than a purely advisory role. We observed stronger AYA engagement as part of youth-led research components, crowdsourcing , and related participatory activities. At the same time, AYA engagement requires capacity building and mentorship to ensure that AYA are prepared to make a strong and durable contribution.
This analysis has limitations. First, we only examined data from a single research consortium and studies benefited from a cooperative grant mechanism to support milestone achievements. At the same time, four studies included costing data and this will allow an examination of cost-effectiveness. Second, COVID-19 caused disruptions (e.g. interrupted follow-up periods, limited in-person clinic visits) during the second year of the grant, necessitating adaptations of some of the milestones. At the same time, none of the stakeholder milestones were adapted because of COVID-19. Third, given that all eight research studies successfully met their transition milestones, we do not have data from studies who failed to transition to the second phase. Fourth, the degree to which milestones captured essential components of research progress may have been incomplete. Finally, our consortium observed marked differences in youth across countries regarding capacity for engagement, HIV research experience, and cultural context. The capacity for strong youth engagement likely varies between countries.
Our comparative adolescent research data provide concrete steps that researchers, national government stakeholders, and AYA stakeholders can do to enhance adolescent HIV research in LMIC settings. Researchers should integrate AYA engagement into research protocols and anticipate ways that AYA can be involved throughout the life of the study. National government stakeholders should consider how milestone transition research grants can strengthen and incentivize goal-oriented research, making studies more relevant to national priorities. Finally, AYA stakeholders should learn more about research studies in order to understand ways that AYA engagement can be initiated and sustained over time.
We would like to thank Ezienyi Nwanunu and Allison V. Zerbe for helpful comments on an earlier version of this manuscript. They declare no potential conflicts of interest.
This work was supported by Eunice Kennedy Shriver National Institute of Child Health and Human Development of the National Institutes of Health under grants (UG3HD096926, UG3HD096875, UG3HD096915, UG3HD096929, UG3HD096906, UG3HD096914, UG3HD096908, UG3HD096920, UH3HD096926, UH3HD096875, UH3HD096915, UH3HD096929, UH3HD096906, UH3HD096914, UH3HD096908, UH3HD096920) with additional funding from OBSSR, NIMHD, and The National Institutes of Health (National Institute of Allergy and Infectious Diseases project number 1K24AI143471). The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
Conflicts of interest
There are no conflicts of interest.
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