JiPime-JiPrEP Trial

01/20/18- 10/31/22
NIH R01 MH113572, MPIs: JM Baeten (UW), K Ngure (JKUAT)
Project Directors: P Mogere (PHRD), K Ortblad (UW)

Oral pre-exposure prophylaxis (PrEP) for HIV prevention is highly effective and being scaled up at public health facilities throughout sub-Saharan Africa. However, barriers to facility-based PrEP delivery, such as frequent (quarterly) facility visits and high opportunity costs for clients, remain. Simplified models of PrEP delivery that improve efficiencies without jeopardizing client outcomes are needed in this setting. In a randomized non-inferiority implementation trial, we tested a model of 6-month PrEP dispensing supported with interim HIV self-testing (HIVST) at 3 months to reduce the number of PrEP facility visits in half. Eligible participants were ≥18 years old and had taken PrEP for one month. We randomized participants 2:1 to: 1) 6-month PrEP dispensing (with semiannual healthcare facility visits, supported with HIVST at three months) or 2) standard-of-care PrEP delivery (three-month PrEP dispensing with quarterly facility visits), Fig 1. Our primary outcomes, measured at 6 months, were HIV testing (any testing between enrollment and the 6-month visit), PrEP refilling, and PrEP adherence (any detectable tenofovir-diphosphate in dried blood spots). This trial was conducted from May 2018 to February 2020, and the primary findings were recently published in the Lancet HIV (Ngure et al, 2022). 

Publications

1. Ortblad KF, Kearney J, Mugywanya K, Irungu EI, Haberer JE, Barnabas RV, Donnell D, Mugo NR, Baeten JM, Ngure K. HIV-1 self-testing to improve the efficiency of PrEP delivery: a randomized controlled trial in Kenya. Trials. 2019; 20(1): 396. [original work]. PMCID: 6610957.
2. Ngure K, Ortblad KF, Mogere P, Thomas K, Mangale D, Kiptinness C, Gakuo S, Mbaire S, Nyokabi J, Bardon AR, Mugo NR, Baeten JM. Efficiency of 6-month PrEP dispensing with HIV self-testing in Kenya: an open-label, randomized, non-inferiority implementation trial. Lancet HIV. 2022; 9(7): E464-E473. [randomized trial].

Conference Presentations

1. Mogere P^, Ortblad KF, Kearney J, Mwathi J, Ndungu G, Nyokabi J, Kiptinness C, Mugo N, Baeten J, Ngure N. Preferences of HIV testing methods among HIV uninfected PrEP users in Kenya. Poster presentation at INTEREST 2019: 13^th International Conference on HIV treatment, pathogenesis, and prevention research in resource-limited settings, Accra, Ghana, May 14-17, 2019.
2. Ortblad KF, Mogere P, Kearney J, Kiptinness C, Baeten J, Ngure K. PrEP users perceive high community-level PrEP stigma in Kenya. Poster presentation at IAS 2019: 10^th IAS Conference on HIV Science, Mexico City, Mexico, July 21-24, 2019. Abstract TUPEC391.
3. Thuo N, Casmir E, Ortblad KF, Mogere P, Kearney J, Kiptinness C, Baeten J, Mugo N, Ngure K. Perceptions of HIV self-testing to support PrEP delivery among Kenyan PrEP users. Poster presentation at IAS 2019: 10^th IAS Conference on HIV Science, Mexico City, Mexico, July 21-24, 2019. Abstract TUPEC456.
4. Ngure K, Ortblad KF, Mogere P, Magale D, Kiptinness C, Baeten J. High inconsistent condom use among recent PrEP initiators in Kenya. Poster presentation at INTEREST 2020, Virtual, November 30 - December 4, 2020.
5. Mogere P^, Ortblad KF, Mangale D, Kiptinness C, Baeten J, Ngure K. Low prevalence of likely depression among PrEP users in Kenya. Online abstract at HIVR4P 2021: 4^th HIV Research for Prevention Conference, Virtual, January 27-28 and February 3-4, 2021. Abstract 1,132.
6. Ngure K, Ortblad KF, Mogere P, Bardon AR, Mangale D, Kiptinness C, Gakuo S, Mbarie S, Nyokabi J, Thomas K, Mugo NR, Baeten JM. Six-month PrEP with HIV self-testing to improve delivery in Kenya: a randomized trial. Oral presentation at CROI 2022: 22^nd Conference on Retroviruses and Opportunistic Infections, Virtual, February 12-16, 2022. Abstract 538.
7. Bardon AR^, Ngure K, Mogere P, Mangale D, Chege D, Kiptinness C, Gakuo S, Mbaire S, Anderson P, Mugo NR, Baeten JM, Ortblad KF. A comparison of self-reported PrEP adherence and objective measures in Kenya. Poster presentation at CROI 2022: 22^nd Conference on Retroviruses and Opportunistic Infections, Virtual, February 12-16, 2022. Abstract 00923.
8. Mogere P^, Bardon AR, Kiptinness C, Mugo NR, Baeten JM, Ortblad KF, Ngure K. Interpretation of HIV self-test results among PrEP users in Kenya. Poster presentation at CROI 2022: 22^nd Conference on Retroviruses and Opportunistic Infections, Virtual, February 12-16, 2022. Abstract 01081.
9. Ortblad KF, Mogere P, Bardon AR, Kiptinness C, Mangale D, Gakuo S, Mbaire S, Nyokabi J, Thomas K, Mugo NR, Baeten JM, Ngure K. The effect of six-month PrEP dispensing with interim HIV self-testing on PrEP continuation at 12 months in Kenya: a randomized implementation trial. Oral presentation at AIDS 2022: 24^th International AIDS Conference, Montreal, Canada, July 29 – August 2, 2022.
10. Mangale D^, Ortblad KF, Heitner J, Mogere P, Kiptinness C, Mugo NR, Baeten JM, Ngure K, Barnabas R. Comparing the cost of six-month PrEP dispensing with interim HIV self-testing to the standard-of-care three-month PrEP dispensing with clinic-based testing in Kenya. E-poster presentation at AIDS 2022: 24^th International AIDS Conference, Montreal, Canada, July 29 – August 2, 2022. Abstract EPE237.
11. Bardon A^, Ngure K, Mogere P, Thomas K, Gakuo S, Kiptinness C, Mbaire S, Mangale D, Nyokabi J, Mugo NR, Baeten JM, Ortblad KF. Effects of six-month PrEP with HIV self-testing on sexual behaviors in Kenya. Themed discussion at CROI 2023: 30^th Conference on Retroviruses and Opportunistic Infections, Seattle, USA, February 19-22, 2023. #977.

^Ortblad mentee or team member

HIVST Performance Study

01/31/21-7/31/21
BMGF INV-033052, PI: K Ortblad (Hutch); Kenyan PIs: E Bukusi (KEMRI), K Ngure (JKUAT)
Project Director: D Were (Jhpiego); Project Coordinators: B Kwach (KEMRI)

HIV self-testing (HIVST) could be a powerful tool to increase the efficiency and feasibility of delivering PrEP in private pharmacies by reducing the time pharmacy providers spend serving PrEP clients, thus freeing them up to serve other pharmacy clients. However, due to concerns around both the sensitivity of HIVST kits to detect early infection and individuals’ ability to correctly interpret HIVST results, neither the World Health Organization nor the Kenya Ministry of Health currently recommend using HIVST for PrEP prescribing or dispensing. In this HIVST performance study, which was carried out at 20 private pharmacies in Kisumu County, Kenya, we compared the performance of blood-based (BB) HIVST conducted by clients (with provider assistance available upon request) to rapid diagnostic testing conducted by an HIV Testing Service (HTS) counselor, which is the standard of care for PrEP prescribing/dispensing in Kenya, Fig. 2. The findings from this study will help us understand the potential use of BB HIVST as a tool to increase efficiencies in models of pharmacy-delivered PrEP services and the potential of HIVST to support other models of community-delivered PrEP services (e.g., online delivery).

Conference presentations

1. Ortblad KF, Kwach B, Ongwen P, Zhang S, Asewe M, Harkey K, Omollo V, Odoyo J, Were D, Ngure K, Bukusi E. High performance of blood-based HIV self-tests at private pharmacies in Kenya. Poster presentation at CROI 2023: 30^th Conference on Retroviruses and Opportunistic Infections, Seattle, USA, February 19-22, 2023. #929.

Invited Presentations

1. Ortblad KF, An HIV self-testing performance assessment: study proposal. World Health Organization, Special Meeting. Virtual, August 2021.
2. Ortblad KF, HIV self-testing performance: current evidence & research proposal. Kenya Ministry of Health, National AIDS & STI Control Programme (NASCOP), Special Meeting. Virtual, August 2021. 

WHO Systematic Literature Review

WHO 2022/1223615-0 PI: K Ortblad (Hutch)
Project Director: C Kiptinness (PHRD)

HIVST has the potential to simplify models of PrEP delivery, potentially expanding access to and uptake of PrEP services to those in need. We conducted a systematic literature review to understand the evidence on HIVST use for PrEP delivery. After screening 1,055 records, we included eight: 3 randomized trials and 5 values and preferences studies. None measured PrEP initiation. Most studies occurred in sub-Saharan Africa (7/8) and included different populations. One trial found that HIVST use between quarterly healthcare facility visits as part of an adherence package with biofeedback slightly increased adherence; the other two trials found that HIVST use between or in lieu of quarterly healthcare facility visits had no significant or non-inferior effects on adherence. HIVST to support PrEP delivery was acceptable, feasible, and preferred. HIVST use for PrEP continuation largely resulted in similar outcomes to standard-of-care delivery and was perceived acceptable and feasible. Further research is needed to optimize HIVST use within PrEP programming.

Publications

1. Kiptinness C^, Kuo A, Reedy A, Johnson C, Ngure K, Wagner AD, Ortblad KF. Examining the use of HIV self-testing to support PrEP delivery: a systematic literature review. Curr HIV/AIDS Rep. 2022. In-press. [review].

Conference Presentations

1. Kiptinness C^, Kuo AP, Reedy AM, Johnson C, Ngure K, Wagner AD, Ortblad KF. Examining the use of HIV self-testing to support PrEP initiation and continuation: a systematic literature review. E-poster presentation at AIDS 2022: 24^th International AIDS Conference, Montreal, Canada, July 29 – August 2, 2022.

Invited Presentations

1. Kiptinness C^ and Ortblad KF, Considering HIV self-testing for PrEP initiation, continuation, and monitoring. World Invited Organization (WHO), Expert Meeting. Virtual, November 2021.
2. Kiptinness C^ and Ortblad KF, HIV self-testing to support PrEP delivery: a systematic literature review. World Health Organization (WHO), Meeting on HIV testing issues for PrEP and CAB-LA. Virtual, June 2022.

^Ortblad mentee or team member

Abbreviations
JKUAT: Jomo Kenyatta University
KEMRI: Kenya Medical Research Institute
PHRD: Partners in Health & Research Development
UW: University of Washington