This section introduces how implementation science (IS) theories, models, and frameworks (TMFs) can strengthen HIV prevention and treatment research and programs across the HIV care continuum. IS TMFs for HIV Research offers practical guidance for selecting, combining, adapting, using, and assessing TMFs in HIV contexts and points to example applications.
This continuum encompasses the primary goals of the four pillars to end the HIV epidemic (EHE) in the United States – and abroad:
- Diagnose: Increase HIV testing to diagnose all people with HIV as early as possible
- Treat: Rapidly link people with HIV to effective antiretroviral treatments (ART) to reach and sustain viral suppression;
- Prevent: To prevent new HIV transmissions, rapidly link people to HIV to evidence-based prevention interventions, including sexual health services like Pre-exposure Prophylaxis (PrEP), post-exposure prophylaxis (PEP), and harm reduction services such as syringe service programs (SSPs) during periods of heightened vulnerability
- Respond: Quickly respond to potential HIV outbreaks with evidence-based HIV prevention and treatment services
https://www.hiv.gov/federal-response/ending-the-hiv-epidemic/key-strategies
Using TMFs in HIV means applying structured, theory-informed tools (e.g., CFIR, PRISM, RE-AIM, TDF, EPIS, HEIF, Proctor’s outcomes) to plan, implement, evaluate, and sustain access to HIV interventions (e.g., HIV testing, ART, PrEP, PEP, harm reduction) and key clinical outcomes (e.g., HIV incidence, ART/PrEP initiation, ART adherence/PrEP persistence, retention in care, viral suppression) and co-morbidities (e.g., sexually transmitted infections [STIs], tuberculosis [TB], mental health, substance use) in real-world settings.
TMFs help teams to:
- Map determinants across levels (policy, organization, clinic, provider, patient, and organizational/social networks).
- Specify the mechanisms and pathways from strategies to outcomes.
- Select, tailor, and test implementation strategies that fit local contexts.
- Measure implementation outcomes (e.g., reach, adoption, fidelity, cost, equity, sustainment) alongside key HIV outcomes (e.g., incidence, viral load, suppression).
- The HIV care continuum is multi-level and dynamic; TMFs make complexity manageable and testable.
- TMFs facilitate scale-up by making assumptions explicit and guiding decisions to support adaptations with fidelity to function (i.e., core components).
- TMFs enable comparability and learning across sites, populations, and strategies (e.g., differentiated service delivery, community-led approaches).
- TMFs can elevate structural and contextual determinants (stigma, criminalization, housing, transportation, reimbursement) that influence inequities in HIV transmission, care, and outcomes.
HIV research and programs often emphasize overlapping dimensions. Call these out explicitly when you apply a TMF. For example:
- HIV Care Continuum: specify what component or linkages along the continuum you are focusing on (e.g., HIV testing, increasing access or linkage to specific HIV services, ART initiation, PrEP adherence/retention, viral suppression, HIV care re-engagement).
- Structural/contextual determinants: specify what drivers affect the communities you are working with (e.g., specific stigmas related to health or social statuses like racism, immigration, homophobia/transphobia, criminalization related to sex work or drug use, or resource insecurity related to housing, income, or transportation).
- Service integration: specify how services for HIV-related comorbidities would be addressed (e.g., STIs, TB, mental health, substance use, maternal/child health, primary care).
- Priority populations: specify which populations vulnerable to HIV you are working with (e.g., youth, men who have sex with men (MSM,) transgender people who have sex with men, people who inject drugs, people engaged in sex work, and people who are unhoused, justice-involved, or migrants).
- Delivery models: specify how the evidence-based interventions are made available to the priority populations (i.e., community-led, peer-delivered, mobile/outreach, telehealth, pharmacy-based, differentiated service delivery.
- Equity & ethics: specify how processes to enhance equity will be applied (e.g., meaningful community engagement, data sovereignty [e.g., tribal or community review/ownership], confidentiality, trust, power-sharing).
The following strategies and considerations can be taken into account when selecting HIV-relevant TMFs:
- Match scope to question: determinant frameworks (e.g., CFIR, EPIS) to identify barriers/facilitators; evaluation frameworks (e.g., RE-AIM, Proctor outcomes) to define/measure success; context-and-equity-attentive frameworks (e.g., PRISM, HEIF) to intentionally offset extant inequities driving HIV transmission and related outcomes.
- Continuum mapping: ensure the TMF covers the stage(s) of the care continuum you target (e.g., PrEP persistence vs. ART initiation).
- Setting & scale: for multi-site or scale-up of evidence-based interventions, favor TMFs with strong context and sustainment constructs (e.g., PRISM, EPIS, Dynamic Sustainability).
- Community partnership: if community engagement and leadership is central, select TMFs that pair well with participatory approaches (e.g., co-design, community-based participatory research [CBPR]).
The following strategies and considerations can be taken into account when combining TMFs for HIV:
- Pair a determinant TMF (e.g., EPIS/TDF) with an evaluation TMF (e.g., RE-AIM/Proctor outcomes) to connect why things happen to what success looks like. Some TMFs already include both determinants and outcomes (e.g., PRISM/CFIR 2.0).
- Add equity-focused frameworks (e.g., HEIF) to make structural/contextual determinants and equity outcomes explicit.
- Use a logic model (theory of change) to align constructs across TMFs and avoid redundancy.
The following strategies and considerations can be taken into account when adapting D&I TMFs for HIV:
- Name HIV-salient structural/contextual determinants (e.g., anticipated stigma, criminalization risk, confidentiality norms, peer trust) within existing TMF domains.
- Articulate inner setting factors specific to where the evidence-based intervention(s) are implemented (e.g., mobile medical units, federally qualified health centers [FQHC]’s, community-based organizations [CBOs], public health clinics, university hospitals)
- Make outer setting concrete (Medicaid reimbursement, 340B, pharmacy regulations, public health mandates, data sharing rules, procurement).
- Embed equity constructs (e.g., cultural safety, anti-racism, data sovereignty, language justice) and specify who decides on adaptations and how (FRAME/FRAME-IS).
- Add diffusion elements for interpersonal (e.g., partner services, peer-led strategies) or socially networked interventions (e.g., changing norms or distributing services through injection or sexual networks).
The following strategies and considerations can be taken into account when using HIV-relevant TMFs in D&I:
- Up front: write aims, hypotheses, implementation strategies, implementation mechanisms, and implementation outcomes using TMF terms; pre-specify primary implementation outcomes (e.g., Reach, Effectiveness, Adoption, Acceptability, Appropriateness, Feasibility, Fidelity, Sustainment), and clinical outcomes (e.g., PrEP persistence at 6 and 12 months; ART initiation within 30 days of initial HIV diagnosis).
- Implementation Strategy selection: use determinant–strategy matching tools (e.g., ERIC crosswalks) and specify function vs. form to guide fidelity-consistent adaptation. To learn more about functions and forms please see work by Perez Jolles et al. and visit the Function and Form toolkit.
- Measurement: align process + implementation + equity + HIV outcomes; plan for mixed methods to explain what worked for whom, where, and why. More on this under Assess.
- Reporting: use established checklists and standards (i.e.,TIDieR, StaRI), and TMF-aligned reporting (e.g., reporting on how you operationalized components of the RE-AIM framework you selected to evaluate) to improve reproducibility and scale-up potential.
The following strategies and considerations can be taken into account when assessing HIV-related TMFs
- Define constructs precisely (e.g., articulate inner setting constructs to specific EPIS stages, specify who constitutes the numerator and denominator in assessing Reach, articulate at what level adoption is being assessed [clinic vs. provider vs. pharmacy]).
- Use validated measures where possible (e.g., using ICS to assess implementation climate, using ILS to assess implementation leadership, using the SU-SMS to assess substance use stigma), and document equity-relevant variables (race/ethnicity, SOGI, housing, justice involvement) .
- Track adaptations over time with FRAME/FRAME-IS and link to implementation outcomes (e.g., RE-AIM domains) and HIV clinical outcomes (e.g., PrEP persistence at 6 and 12 months; ART initiation within 30 days of initial HIV diagnosis).
- PrEP persistence in FQHCs: use CFIR to identify determinants; use ERIC to articulate informed implementation strategies (peer text support, refill synchronization); use RE-AIM to articulate your implementation outcomes (reach/adoption/fidelity; equity metrics) by priority group.
- HIV care re-engagement following incarceration: use EPIS to articulate the outer/community context (e.g., probation, housing, employment), inner/health systems context (e.g., HIV clinic hours/wait times, provider trust, accepted insurance types), and bridging factors (e.g., align housing and clinic workflows with re-entry services) navigated during post-release transitions; use Proctor outcomes to articulate program costs and inform sustainment.
- Community-led HIV testing + linkage to prevention services: use PRISM to center the role patient and provider characteristics (e.g. MSM, CBO, FQHC) with of community/outer setting contexts (CBO-led mobile HIV testing outside of popular bars) and health systems/inner setting contexts (PrEP enrollment and navigation services); apply RE-AIM + qualitative comparative analysis (QCA) to identify effective implementation strategy bundles across sites.
- Network-based harm reduction: use TDF to target provider behavior change (prescribe naloxone, provide PEP/PrEP referrals to patients to distribute to their sexual and injection partners); use CFIR to assess organizational readiness for expanding services to network partners, use RE-AIM + equity monitoring frameworks to assess expanded reach and adoption among patients’ network members.
| TMF | Primary Reference | Population | Sector | Geographic Location | Type of Study | HIV/AIDS Pillar |
|---|---|---|---|---|---|---|
| RE-AIM 1.0 Framework | Brant AR, Dhillon P, Hull S, Coleman M, Ye PP, Lotke PS, Folan J, Scott RK. Integrating HIV Pre-Exposure Prophylaxis into Family Planning Care: A RE-AIM Framework Evaluation. AIDS Patient Care STDS. 2020 Jun;34(6):259-266. doi: 10.1089/apc.2020.0004. PMID: 32484743; PMCID: PMC7262643. https://pubmed.ncbi.nlm.nih.gov/32484743/ | Primarily African- American patients under 30 years old who are publicly insured and self-refer for abortion and contraceptive services | Specialized HIV care clinics | Washington, DC | Mixed methods | Diagnose; Prevent |
| RE-AIM 2.0/Contextually Expanded RE-AIM | Brant AR, Dhillon P, Hull S, Coleman M, Ye PP, Lotke PS, Folan J, Scott RK. Integrating HIV Pre-Exposure Prophylaxis into Family Planning Care: A RE-AIM Framework Evaluation. AIDS Patient Care STDS. 2020 Jun;34(6):259-266. doi: 10.1089/apc.2020.0004. PMID: 32484743; PMCID: PMC7262643. https://pubmed.ncbi.nlm.nih.gov/32484743/ | Primarily African- American patients under 30 years old who are publicly insured and self-refer for abortion and contraceptive services | Specialized HIV care clinics | Washington, DC | Mixed methods | Diagnose; Prevent |
Do:
- Co-create a theory of change that ties your TMFs to the HIV care continuum stage(s).
- Pre-specify mechanisms (e.g., reducing anticipated HIV stigma → increased PrEP persistence) and test them.
Avoid:
- “Name-dropping” a TMF without using it to inform your research aims, measures, and analyses.
- Ignoring outer setting (policy, financing, supply chain) when scaling.
- Treating adaptation as ad-hoc; log adaptations and link them to outcomes.
Use the D&I Models webtool to explore TMFs, compare constructs, and link to measures; adopt the select–combine–adapt–use–assess flow shown here, swapping in HIV-specific content, implementation and HIV clinical outcomes, and examples.