NCT02994355

HIV Testing at Family Planning Clinics in Mombasa County, Kenya

Completed NA Results posted Last updated 30 November 2023

What this trial tests

NA trial testing Systems Analysis and Improvement Approach in HIV in 24 participants. Completed in 31 December 2022.

Timeline

1 June 2018

Primary endpoint
31 December 2019

31 December 2022

Quick facts

Lead sponsor	University of Washington
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	screening
Enrollment	24
Start date	1 June 2018
Primary completion	31 December 2019
Estimated completion	31 December 2022
Sites	24 locations across Kenya

Drugs / interventions tested

• Systems Analysis and Improvement Approach

Conditions studied

• HIV — all drugs for HIV →

Sponsor

University of Washington

Who can join

Eligibility, any sex, with HIV. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Eligible (Not Known HIV+) New FP Clients Who Are Tested for HIV in the Months 9-12 of the Study in Intervention and Control Facilities Primary · Months 9-12 of the study

Group	Value	95% CI
Intervention Clinics	42	± 26
Control Clinics	32	± 15

Percentage of New FP Clients Who Are Counseled About HIV Testing in the Months 9-12 of the Study in Intervention and Control Facilities, Adjusted for Baseline Secondary · Months 9-12 of the study

Group	Value	95% CI
Intervention Clinics	85	± 27
Control Clinics	67	± 34

Percentage of New FP Clients Who Are Tested for HIV After Year of Minimal Support Secondary · Months 13-24 of the study

Group	Value	95% CI
Intervention Clinics	61	± 7
Control Clinics	19	± 6

Sponsor's own description

Location: Family Planning Clinics in Mombasa County, Kenya

Introduction:

Integration of HIV treatment and prevention with family planning (FP) services is a promising approach for optimizing delivery of comprehensive healthcare for HIV-positive women, as well as prevention services for those who are negative. In Mombasa County, the USAID-supported AIDS Population and Health Integrated Assistance II Program revised the FP Clinic Register to capture HIV testing in 2008. However, the rate of HIV testing in FP clinics remains low. Our overarching objective is to assess the effectiveness, costs, and budget impact of implementing the systems analysis and improvement approach (SAIA) to increase HIV testing in FP clinics in Mombasa County.

Methods:

The investigators aim to conduct a cluster-randomized trial comparing the effect of the SAIA approach versus usual procedures on rates of HIV testing in first-time attendees at 20 intervention versus 20 control FP clinics in Mombasa County. The investigators will compare HIV testing rates for first-time FP clinic attendees in SAIA intervention versus control facilities after an additional year, during which FP clinics in the intervention arm will be encouraged to continue to use the SAIA tools with minimal support from the study team as the Mombasa County Ministry of Health will take ownership of implementation. Lastly, the investigators aim to estimate the incremental cost and budget impact of applying SAIA versus standard of care using an activity-based approach.

Anticipated Results:

The investigators anticipate that SAIA will produce significant and sustained improvement in HIV-testing rates in first-time FP clinic attendees in intervention clinics compared to control facilities. The use of a rigorous study design will provide strong evidence to guide integration of HIV testing into FP services in a wide range of settings. The inclusion of costing and budget impact analyses will assist policy makers in reaching informed decisions about implementation.

Anticipated Conclusion:

By addressing the crucial first step in the linkage of HIV and FP services, this research holds considerable promise for improving women's health by opening the gateway to HIV care and prevention.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Results of a cluster randomized trial testing the systems analysis and improvement approach to increase HIV testing in family planning clinics.
   Eastment MC, Wanje G, Richardson BA, Mwaringa E, et al · · 2022 · cited 11× · PMID 34628439 · DOI 10.1097/qad.0000000000003099
2. Assessing the sustainability of the Systems Analysis and Improvement Approach to increase HIV testing in family planning clinics in Mombasa, Kenya: results of a cluster randomized trial.
   Long JE, Eastment MC, Wanje G, Richardson BA, et al · · 2022 · cited 7× · PMID 36195890 · DOI 10.1186/s13012-022-01242-3
3. The cost of implementing the Systems Analysis and Improvement Approach for a cluster randomized trial integrating HIV testing into family planning services in Mombasa County, Kenya.
   Thomas D, Wanje G, Eastment MC, McClelland RS, et al · · 2022 · cited 2× · PMID 36471311 · DOI 10.1186/s12913-022-08828-z
4. Qualitative evaluation of the Systems Analysis and Improvement Approach as a strategy to increase HIV testing in family planning clinics using the Consolidated Framework for Implementation Research and the Implementation Outcomes Framework.
   Eastment MC, Long JE, Wanje G, Richardson BA, et al · · 2022 · cited 2× · PMID 36076250 · DOI 10.1186/s43058-022-00342-x
5. Cross-sectional study evaluating organizational climate, change commitment, and change efficacy for predicting family planning clinics' success in increasing HIV counseling and testing in Mombasa, Kenya.
   Kwendakwema CN, Eastment MC, Wanje G, Richardson BA, et al · · 2025 · cited 1× · PMID 41474700 · DOI 10.1371/journal.pgph.0005542