HivFP HIV SCALENCT05404958
Systems Analysis and Improvement Approach to Improve Integration of HIV Prevention and Treatment Services
A study testing Systems Analysis and Improvement Approach (SAIA) in people with Hiv, run by University of Washington at 1 site in Kenya.
Trial summary
East and Southern Africa is home to 6.2% of the world's population but includes 54% of all people living with HIV (PLWH). In this region, three out of five PLWH are women, and there is a particularly high burden of HIV amongst adolescent girls and young women (AGYW). Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Hiv
- What is being tested?
- Systems Analysis and Improvement Approach (SAIA)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteKenya
- Study dates
- 14 Mar 2024to 1 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- FP clinics:
- -All FP clinics that receive County-supplied FP products will be eligible to participate.
- FP clinic managers and staff:
- -Any FP clinic manager that is 18 years and older is eligible to be interviewed. -These clinic managers can be male or female.
- Kenyan public health staff:
- Any Kenyan public health staff that is 18 years and older is eligible to be interviewed.
- These public health staff can be male or female.
Who cannot join
- FP clinics:
- Any clinics that are expected to close within the next year at the time of study initiation
- 12 facilities that participated as SAIA intervention facilities in our small-scale trial where the intervention was led by research staff.
- FP clinic managers and staff: No exclusion criteria Kenyan public health staff: No exclusion criteria
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Kenya1 site, 1 recruiting
- Recruiting
FP Clinics in Mombasa County
Mombasa
George Wanje
About this study
East and Southern Africa is home to 6.2% of the world's population but includes 54% of all people living with HIV (PLWH). In this region, three out of five PLWH are women, and there is a particularly high burden of HIV amongst adolescent girls and young women (AGYW). Over half of African women use family planning (FP) services. Integration of HIV prevention and treatment with FP services holds promise for supporting progress toward the UNAIDS 95-95-95 targets for testing, treatment, and prevention. Nonetheless, integration of even basic HIV prevention and treatment services into FP clinics remains low and how best to integrate these services is still unknown. In a previous trial, the Systems Analysis and Improvement Approach (SAIA), was an effective implementation strategy for improving HIV counseling and testing in a small selection of FP clinics in Mombasa County, Kenya when delivered by research staff. SAIA incorporates a cascade analysis tool, sequential process flow mapping, and cycles of micro-intervention development, implementation, and assessment to improve a care cascade. More data is needed to understand if SAIA is effective for also improving linkage to HIV care and screening and linkage to pre-exposure prophylaxis (PrEP) in FP clinics when SAIA is delivered at scale by Kenyan public health workforce. The first objective of this study is to conduct a cluster-randomized trial evaluating the effectiveness of SAIA versus control (usual procedures with no specific intervention) for increasing HIV counseling, testing, linkage to HIV care, and screening and linkage to PrEP in new FP clients and new and returning AGYW clients. There will be a particular focus on the HIV prevention and treatment of AGYW in this study and any AGYW presenting for FP care will be prioritized. Quantitative and qualitative data will be analyzed using the RE-AIM framework to evaluate the program's Reach, Effectiveness, Adoption, Implementation, and Maintenance. To understand how SAIA could be integrated into national Ministry of Health policies and programs, activity-based costing will be conducted to estimate the budget and program impacts of SAIA, scaled to a County level, from a Ministry of Health perspective. It is hypothesized that compared to control, SAIA will be effective at increasing HIV counseling, HIV testing, linkage to HIV care, and screening and linkage to PrEP for new FP clients and all new and returning AGYW FP clients when delivered at scale by Kenyan public health staff. The implementation evaluation, costing, and budget impact analysis will establish a road map for national-level implementation, positioning Kenya as a global leader in integrating FP/HIV services.
Read the detailed description
AIM 1: To conduct a cluster-randomized trial evaluating the effectiveness of SAIA versus control (usual procedures) for increasing HIV counseling, testing, linkage to care, and screening and linkage to PrEP in new FP clients and new and returning AGYW clients. Quantitative and qualitative data will be analyzed using the RE-AIM framework (21).
1a) Reach: Proportion of intervention arm health facility clients' reached with the intervention
1b) Effectiveness: Compare the effectiveness of SAIA vs. control for increasing rates of HIV counseling, testing, linkage to care, and screening and linkage to PrEP in new FP clients and new and returning AGYW clients
1c) Adoption: Proportion of clinics adopting SAIA; adoption determinants identified using the Implementation Research Logic Model (IRLM) (22) and Organizational Readiness for Implementing Change (ORIC) scale (23)
1d) Implementation: Proportion of FP clinics implementing SAIA with high fidelity at 12 months and at 24 months; barriers and facilitators of implementation at scale by County DOH personnel will be explored using constructs from the Consolidated Framework for Implementation Research (CFIR) and the IRLM (24)
1e) Maintenance: Proportion of FP clinics maintaining SAIA at 12 months and 24 months after introduction AIM 2: To estimate the incremental cost and budget and program impacts of SAIA from a County DOH perspective. We will conduct activity-based costing and develop budget impact scenarios based on SAIA's adoption.
- Conditions
- Hiv
- Being tested
- Systems Analysis and Improvement Approach (SAIA)
- Keywords
- HIV prevention and treatment, Family planning, PrEP
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Systems Analysis and Improvement Approach (SAIA)Other
What is SAIA? It is a 5-step cycle that is repeated every 4-6 weeks for continuous quality improvement, implemented by Kenyan public health workforce and FP clinic staff, and monitored by Mombasa DOH.
Step 1: Understanding the cascade from FP clinic enrollment to HIV testing to linkage to treatment and prevention services.
Step 2: Use process mapping to identify modifiable bottlenecks. Step 3: Define and implement workflow adaptations to eliminate modifiable bottlenecks.
Step 4: Monitor change in performance. Step 5: Repeat the analysis and improvement cycle (steps 1-4).
| Study group | Role | What they receive |
|---|---|---|
| Intervention clinics that implement the Systems Analysis and Improvement Approach | Experimental | Mombasa County public health staff will facilitate SAIA Receives: Other: Systems Analysis and Improvement Approach (SAIA) |
| Usual procedures | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness HIV counseling
Proportion of new FP clients and all AGYW clients that are counseled for HIV out of the total new FP clients and AGYW in intervention vs control clinics
Measured: Months 1-24
Effectiveness HIV testing
Proportion of new FP clients and all AGYW tested for HIV out of the total new FP clients and all AGYW who are eligible to be tested in intervention vs control clinics
Measured: Months 1-24
Effectiveness Linked to HIV care
Proportion of HIV-seropositive new FP clients and all HIV-seropositive AGYW clients linked to comprehensive HIV care out of all HIV-seropositive new FP clients and all HIV-seropositive AGYW clients in intervention vs control clinics
Measured: Months 1-24
Effectiveness Screening for PrEP
- Proportion of new FP clients and all AGYW clients screened for PrEP out of all new FP clients and all AGYW clients who were counseled for HIV in intervention vs control clinics
Measured: Months 1-24
Effectiveness linkage to PrEP
Proportion of new FP clients and all AGYW clients who are eligible for PrEP who are linked to PrEP out of all new FP clients and all AGYW who are eligible for PrEP in intervention vs control clinics
Measured: 1-24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2022
- Study start14 Mar 2024
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HivStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a cluster randomized trial enrolling family planning clinics. "Participants" are FP clinics.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, McKenna Eastment, University of Washington
- Investigators
- McKenna Eastment, MD, MPH, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05404958
- Sponsor's protocol ID
- STUDY00014745
- Other IDs
- GRANT13455302
- Acronym
- FP HIV SCALE
- Status last verified
- Apr 2026
- First submitted
- 24 May 2022
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systems Analysis and Improvement Approach to Improve Integration of HIV Prevention and Treatment Services
- ClinicalTrials.gov ID
- NCT05404958
- Acronym / sponsor ID
- FP HIV SCALE / STUDY00014745
- Conditions
- Hiv
- Keywords
- HIV prevention and treatment, Family planning, PrEP
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 14 Mar 2024 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 3 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
East and Southern Africa is home to 6.2% of the world's population but includes 54% of all people living with HIV (PLWH). In this region, three out of five PLWH are women, and there is a particularly high burden of HIV amongst adolescent girls and young women (AGYW). Over half of African women use family planning (FP) services. Integration of HIV prevention and treatment with FP services holds promise for supporting progress toward the UNAIDS 95-95-95 targets for testing, treatment, and prevention. Nonetheless, integration of even basic HIV prevention and treatment services into FP clinics remains low and how best to integrate these services is still unknown. In a previous trial, the Systems Analysis and Improvement Approach (SAIA), was an effective implementation strategy for improving HIV counseling and testing in a small selection of FP clinics in Mombasa County, Kenya when delivered by research staff. SAIA incorporates a cascade analysis tool, sequential process flow mapping, and cycles of micro-intervention development, implementation, and assessment to improve a care cascade. More data is needed to understand if SAIA is effective for also improving linkage to HIV care and screening and linkage to pre-exposure prophylaxis (PrEP) in FP clinics when SAIA is delivered at scale by Kenyan public health workforce. The first objective of this study is to conduct a cluster-randomized trial evaluating the effectiveness of SAIA versus control (usual procedures with no specific intervention) for increasing HIV counseling, testing, linkage to HIV care, and screening and linkage to PrEP in new FP clients and new and returning AGYW clients. There will be a particular focus on the HIV prevention and treatment of AGYW in this study and any AGYW presenting for FP care will be prioritized. Quantitative and qualitative data will be analyzed using the RE-AIM framework to evaluate the program's Reach, Effectiveness, Adoption, Implementation, and Maintenance. To understand how SAIA could be integrated into national Ministry of Health policies and programs, activity-based costing will be conducted to estimate the budget and program impacts of SAIA, scaled to a County level, from a Ministry of Health perspective. It is hypothesized that compared to control, SAIA will be effective at increasing HIV counseling, HIV testing, linkage to HIV care, and screening and linkage to PrEP for new FP clients and all new and returning AGYW FP clients when delivered at scale by Kenyan public health staff. The implementation evaluation, costing, and budget impact analysis will establish a road map for national-level implementation, positioning Kenya as a global leader in integrating FP/HIV services.
Detailed description
AIM 1: To conduct a cluster-randomized trial evaluating the effectiveness of SAIA versus control (usual procedures) for increasing HIV counseling, testing, linkage to care, and screening and linkage to PrEP in new FP clients and new and returning AGYW clients. Quantitative and qualitative data will be analyzed using the RE-AIM framework (21).
1a) Reach: Proportion of intervention arm health facility clients' reached with the intervention
1b) Effectiveness: Compare the effectiveness of SAIA vs. control for increasing rates of HIV counseling, testing, linkage to care, and screening and linkage to PrEP in new FP clients and new and returning AGYW clients
1c) Adoption: Proportion of clinics adopting SAIA; adoption determinants identified using the Implementation Research Logic Model (IRLM) (22) and Organizational Readiness for Implementing Change (ORIC) scale (23)
1d) Implementation: Proportion of FP clinics implementing SAIA with high fidelity at 12 months and at 24 months; barriers and facilitators of implementation at scale by County DOH personnel will be explored using constructs from the Consolidated Framework for Implementation Research (CFIR) and the IRLM (24)
1e) Maintenance: Proportion of FP clinics maintaining SAIA at 12 months and 24 months after introduction AIM 2: To estimate the incremental cost and budget and program impacts of SAIA from a County DOH perspective. We will conduct activity-based costing and develop budget impact scenarios based on SAIA's adoption.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a cluster randomized trial enrolling family planning clinics. "Participants" are FP clinics.
| Arm | Type | Receives |
|---|---|---|
| Intervention clinics that implement the Systems Analysis and Improvement Approach | Experimental | Other: Systems Analysis and Improvement Approach (SAIA)Mombasa County public health staff will facilitate SAIA |
| Usual procedures | No intervention | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- -All FP clinics that receive County-supplied FP products will be eligible to participate.
- -Any FP clinic manager that is 18 years and older is eligible to be interviewed. -These clinic managers can be male or female.
- Any Kenyan public health staff that is 18 years and older is eligible to be interviewed.
- These public health staff can be male or female.
Key exclusion criteria (4 listed)
- Any clinics that are expected to close within the next year at the time of study initiation
- 12 facilities that participated as SAIA intervention facilities in our small-scale trial where the intervention was led by research staff.
- FP clinic managers and staff: No exclusion criteria Kenyan public health staff: No exclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Systems Analysis and Improvement Approach (SAIA)What is SAIA? It is a 5-step cycle that is repeated every 4-6 weeks for continuous quality improvement, implemented by Kenyan public health workforce and FP clinic staff, and monitored by Mombasa DOH. Step 1: Understanding the cascade from FP clinic enrollment to HIV testing to linkage to treatment and prevention services. Step 2: Use process mapping to identify modifiable bottlenecks. Step 3: Define and implement workflow adaptations to eliminate modifiable bottlenecks. Step 4: Monitor change in performance. Step 5: Repeat the analysis and improvement cycle (steps 1-4). | Other | Intervention clinics that implement the Systems Analysis and Improvement Approach |
Primary outcome
Effectiveness HIV counseling
Time frame: Months 1-24
Proportion of new FP clients and all AGYW clients that are counseled for HIV out of the total new FP clients and AGYW in intervention vs control clinics
Effectiveness HIV testing
Time frame: Months 1-24
Proportion of new FP clients and all AGYW tested for HIV out of the total new FP clients and all AGYW who are eligible to be tested in intervention vs control clinics
Effectiveness Linked to HIV care
Time frame: Months 1-24
Proportion of HIV-seropositive new FP clients and all HIV-seropositive AGYW clients linked to comprehensive HIV care out of all HIV-seropositive new FP clients and all HIV-seropositive AGYW clients in intervention vs control clinics
Effectiveness Screening for PrEP
Time frame: Months 1-24
1. Proportion of new FP clients and all AGYW clients screened for PrEP out of all new FP clients and all AGYW clients who were counseled for HIV in intervention vs control clinics
Effectiveness linkage to PrEP
Time frame: 1-24 months
Proportion of new FP clients and all AGYW clients who are eligible for PrEP who are linked to PrEP out of all new FP clients and all AGYW who are eligible for PrEP in intervention vs control clinics
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
McKenna Eastment, MD, MPH principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Systems Analysis and Improvement Approach (SAIA) in people with Hiv, run by University of Washington at 1 site in Kenya.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact McKenna Eastment (206-4165074, mceast@uw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness HIV counseling (time frame: Months 1-24). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.