Ruanne V. Barnabas Archives - Implementation Science at UW

✪ 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

Abstract:

Background

In Kenya, HIV incidence is highest among reproductive-age women. A key HIV mitigation strategy is the integration of HIV testing and counseling (HTC) into family planning services, but successful integration remains problematic. We conducted a cluster-randomized trial using the Systems Analysis and Improvement Approach (SAIA) to identify and address bottlenecks in HTC integration in family planning clinics in Mombasa County, Kenya. This trial (1) assessed the efficacy of this approach and (2) examined if SAIA could be sustainably incorporated into the Department of Health Services (DOHS) programmatic activities. In Stage 1, SAIA was effective at increasing HTC uptake. Here, we present Stage 2, which assessed if SAIA delivery would be sustained when implemented by the Mombasa County DOHS and if high HTC performance would continue to be observed.

Methods

Twenty-four family planning clinics in Mombasa County were randomized to either the SAIA implementation strategy or standard care. In Stage 1, the study staff conducted all study activities. In Stage 2, we transitioned SAIA implementation to DOHS staff and compared HTC in the intervention versus control clinics 1-year post-transition. Study staff provided training and minimal support to DOHS implementers and collected quarterly HTC outcome data. Interviews were conducted with family planning clinic staff to assess barriers and facilitators to sustaining HTC delivery.

Results

Only 39% (56/144) of planned SAIA visits were completed, largely due to the COVID-19 pandemic and a prolonged healthcare worker strike. In the final study quarter, 81.6% (160/196) of new clients at intervention facilities received HIV counseling, compared to 22.4% (55/245) in control facilities (prevalence rate ratio [PRR]=3.64, 95% confidence interval [CI]=2.68–4.94). HIV testing was conducted with 60.5% (118/195) of new family planning clients in intervention clinics, compared to 18.8% (45/240) in control clinics (PRR=3.23, 95% CI=2.29–4.55). Interviews with family planning clinic staff suggested institutionalization contributed to sustained HTC delivery, facilitated by low implementation strategy complexity and continued oversight.

Conclusions

Intervention clinics demonstrated sustained improvement in HTC after SAIA was transitioned to DOHS leadership despite wide-scale healthcare disruptions and incomplete delivery of the implementation strategy. These findings suggest that system interventions may be sustained when integrated into DOHS programmatic activities.

Trial registration

ClinicalTrials.gov (NCT02994355) registered on 16 December 2016.

^{**This abstract is posted with permission under the Creative Commons Attribution 4.0 International License**}

✪ Low costs and opportunities for efficiency: a cost analysis of the first year of programmatic PrEP delivery in Kenya’s public sector

Abstract:

Background

In 2017, the Kenyan Ministry of Health integrated provision of pre-exposure prophylaxis (PrEP) into public HIV-1 care clinics as a key component of the national HIV-1 prevention strategy. Estimates of the cost of PrEP provision are needed to inform the affordability and cost-effectiveness of PrEP in Kenya.

Methods

We conducted activity-based micro-costing from the payer perspective to estimate both the financial and economic costs of all resources and activities required to provide PrEP in Kenya’s public sector. We estimated total and unit costs in 2019 United States dollars from a combination of project expense reports, Ministry of Health training reports, clinic staff interviews, time-and-motion observations, and routinely collected data from PrEP recipient files from 25 high-volume HIV-1 care clinics.

Results

In the first year of programmatic PrEP delivery in 25 HIV-1 care clinics, 2,567 persons initiated PrEP and accrued 8,847 total months of PrEP coverage, accounting for 2 % of total outpatient clinic visits. The total financial cost to the Ministry of Health was $91,175, translating to an average of $10.31 per person per month. The majority (69 %) of financial costs were attributable to PrEP medication, followed by administrative supplies (17 %) and training (9 %). Economic costs were higher ($188,584 total; $21.32 per person per month) due to the inclusion of the opportunity cost of staff time re-allocated to provide PrEP and a proportional fraction of facility overhead. The vast majority (88 %) of the annual $80,811 economic cost of personnel time was incurred during activities to recruit new clients (e.g., discussion of PrEP within HIV-1 testing and counseling services), while the remaining 12 % was for activities related to both initiation and maintenance of PrEP provision (e.g., client consultations, technical advising, support groups).

Conclusions

Integration of PrEP provision into existing public health HIV-1 care service delivery platforms resulted in minimal additional staff burden and low incremental costs. Efforts to improve the efficiency of PrEP provision should focus on reductions in the cost of PrEP medication and extra-clinic demand creation and community sensitization to reduce personnel time dedicated to recruitment-related activities.

Trial registration

ClinicalTrials.gov registration NCT03052010. Retrospectively registered on February 14, 2017.

^{**This abstract is posted with permission under the Creative Commons Attribution 4.0 International License**}

✪ Prevention of cervical cancer through two HPV-based screen-and-treat implementation models in Malawi: Protocol for a cluster randomized feasibility trial

Abstract:

Background

Cervical cancer is the leading cause of cancer incidence and mortality among Malawian women, despite being a largely preventable disease. Implementing a cervical cancer screening and preventive treatment (CCSPT) program that utilizes rapid human papillomavirus (HPV) testing on self-collected cervicovaginal samples for screening and thermal ablation for treatment may achieve greater coverage than current programs that use visual inspection with acetic acid (VIA) for screening and cryotherapy for treatment. Furthermore, self-sampling creates the opportunity for community-based screening to increase uptake in populations with low screening rates. Malawi’s public health system utilizes regularly scheduled outreach and village-based clinics to provide routine health services like family planning. Cancer screening is not yet included in these community services. Incorporating self-sampled HPV testing into national policy could address cervical cancer screening barriers in Malawi, though at present the effectiveness, acceptability, appropriateness, feasibility, and cost-effectiveness still need to be demonstrated.

Methods

We designed a cluster randomized feasibility trial to determine the effectiveness, acceptability, appropriateness, feasibility, and budget impact of two models for integrating a HPV-based CCSPT program into family planning (FP) services in Malawi: model 1 involves only clinic-based self-sampled HPV testing, whereas model 2 includes both clinic-based and community-based self-sampled HPV testing. Our algorithm involves self-collection of samples for HPV GeneXpert® testing, visual inspection with acetic acid for HPV-positive women to determine ablative treatment eligibility, and same-day thermal ablation for treatment-eligible women. Interventions will be implemented at 14 selected facilities. Our primary outcome will be the uptake of cervical cancer screening and family planning services during the 18 months of implementation, which will be measured through an Endline Household Survey. We will also conduct mixed methods assessments to understand the acceptability, appropriateness, and feasibility of the interventions, and a cost analysis to assess budget impact.

Discussion

Our trial will provide in-depth information on the implementation of clinic-only and clinic-and-community models for integrating self-sampled HPV testing CCSPT with FP services in Malawi. Findings will provide valuable insight for policymakers and implementers in Malawi and other resource-limited settings with high cervical cancer burden.

Trial registration

ClinicalTrials.gov identifier: NCT04286243. Registered on February 26, 2020.

^{**This abstract is posted with permission under the Creative Commons Attribution 4.0 International License**}

Implementation and Scale-Up of Integrated Depression Care in South Africa: An Observational Implementation Research Protocol

✪ An implementation study of oral and blood‐based HIV self‐testing and linkage to care among men in rural and peri‐urban KwaZulu‐Natal, South Africa

Abstract:

Introduction

In South Africa, HIV‐infected men are less likely than women to test and know their status (the first UNAIDS “90‐90‐90” target), and men have worse outcomes across the HIV care cascade. HIV self‐testing (HIVST) may address this testing disparity but questions remain over the most effective distribution strategy and linkage following a positive test result. We implemented a men‐focused HIVST distribution programme to evaluate components contributing to participation and retention.

Methods

We conducted an implementation study of multi‐venue HIVST kit distribution in rural and peri‐urban KwaZulu‐Natal (KZN), South Africa. We distributed HIVST kits at community points, workplaces and social venues for on site or take‐home use. Clients could choose blood‐based or oral‐fluid‐based HIVST kits and elect to watch an in‐person or video demonstration. We provided a USD2 incentive to facilitate reporting test results by phone or SMS. Persons with reactive HIVST results were provided immediate confirmatory tests (if used HIVST on site) or were referred for confirmatory testing (if took HIVST off site) and linkage to care for ART initiation. We describe the testing and linkage cascade in this sample and describe predictors of reactive HIVST results and linkage.

Results

Between July and November 2018, we distributed 4496 HIVST kits in two regions of KZN (96% to men, median age 28 (IQR 23 to 35). Most participants (58%) chose blood‐based HIVST and 42% chose oral‐swab kits. 11% of men were testing for the first time. A total of 3902 (83%) of testers reported their test result to the study team, with 314 (8%) screening positive for HIV. Among 274 men with reactive HIVST results, 68% linked to ART; no significant predictors of linkage were identified. 10% of kit users reported they would prefer a different type (oral vs. blood) of kit for repeat testing than the type they used.

Conclusions

HIVST is acceptable to men and rapid distribution with optional testing support is feasible in rural and peri‐urban settings. HIVST kits successfully reached younger men and identified undetected infections. Both oral and blood‐based HIVST were selected. Scaling up HIVST distribution and guidance may increase the number of first‐time testers among men and help achieve the first UNAIDS “90” for men in South Africa.

^{**This abstract is posted with permission under the Creative Commons Attribution 4.0 International License**}

Integration of PrEP Services Into Routine Antenatal and Postnatal Care Experiences From an Implementation Program in Western Kenya

✪ Clinic flow for STI, HIV, and TB patients in an urban infectious disease clinic offering point-of-care testing services in Durban, South Africa

Abstract:

Background

Many clinics in Southern Africa have long waiting times. The implementation of point-of-care (POC) tests to accelerate diagnosis and improve clinical management in resource-limited settings may improve or worsen clinic flow and waiting times. The objective of this study was to describe clinic flow with special emphasis on the impact of POC testing at a large
urban public healthcare clinic in Durban, South Africa.

Methods

We used time and motion methods to directly observe patients and practitioners. We created patient flow maps and recorded individual patient waiting and consultation times for patients seeking STI, TB, or HIV care. We conducted semi-structured interviews with 20 clinic staff to ascertain staff opinions on clinic flow and POC test implementation.

Results

Among 121 observed patients, the total number of queues ranged from 4 to 7 and total visit times ranged from 0:14 (hours:minutes) to 7:38. Patients waited a mean of 2:05 for standard-of-care STI management, and approximately 4:56 for STI POC diagnostic testing. Stable HIV patients who collected antiretroviral therapy refills waited a mean of 2:42 in the standard queue and 2:26 in the fast-track queue. A rapid TB test on a small sample of patients with the Xpert MTB/RIF assay and treatment initiation took a mean of 6:56, and 40% of patients presenting with TB-related symptoms were asked to return for an additional clinic visit to obtain test results. For all groups, the mean clinical assessment time with a nurse
or physician was 7 to 9 min, which accounted for 2 to 6% of total visit time. Staff identified poor clinic flow and personnel shortages as areas of concern that may pose challenges to expanding POC tests in the current clinic environment.

Conclusions

This busy urban clinic had multiple patient queues, long clinical visits, and short clinical encounters. Although POC testing ensured patients received a diagnosis sooner, it more than doubled the time STI patients spent at the clinic and did not result in same-day diagnosis for all patients screened for TB. Further research on implementing POC testing efficiently into care pathways is required to make these promising assays a success.

^{**This abstract is posted with permission under the Creative Commons Attribution 4.0 International License**}

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