LVCT Health

HIV Prevention Research

HIV Prevention Research

Catalyzing access to new prevention products to stop HIV


The overall goal of the study is to assess the feasibility, acceptability, uptake, and patterns of use with a service delivery package providing choice of oral PrEP, PrEP ring, and CAB PrEP among women at PEPFAR/USAID delivery sites in Kenya, Lesotho, South Africa, Uganda, and Zimbabwe. The objectives of this study are (a) Describe the implementation of the service delivery package for PrEP choice for women in PEPFAR/USAID public health service delivery sites, and assess individual-, provider, facility, community and health system-level facilitators and barriers of the implementation process (Achieved through study component 2 (process evaluation) and sub-studies 2a-b) (b)Describe patterns of PrEP use and use effectiveness in the context of PrEP choice, assess implementation and sociodemographic correlates of PrEP use patterns and use effectiveness (Achieved through study component 1 (observational cohort) including sub-study 1b) (c) Describe clinically relevant indicators among PrEP users, including rates of seroconversion and drug resistance among PrEP users who seroconvert following PrEP exposure. (Achieved through study component 1 (observational cohort) including sub-study 1a)

We will accomplish these objectives by conducting a mixed methods implementation study involving several components:

1.    Prospective observational cohort study of women at PEPFAR/USAID delivery sites that are delivering HIV pre-exposure prophylaxis (PrEP), including daily oral PrEP, monthly PrEP ring, and/or bi-monthly CAB PrEP

a.    Descriptive sub-study to evaluate performance characteristics of different HIV testing strategies among participants who initiate CAB PrEP

b.    Descriptive sub-study to evaluate the feasibility and validation of a prevention effective use (PEU) measure for a subset of PrEP users.

2.    Mixed-methods process evaluation involving implementers and key stakeholders.

a.    Costing sub-studies across Lesotho and Uganda study sites

b.    Qualitative sub-study to understand community acceptance of PrEP

Our study population comprise: HIV-negative women* attending PEPFAR/USAID supported facilities who are interested in using PrEP, including the following sub-groups:

·         Cisgender adolescent girls and young women (AGYW) ages 15-24 (depending on national minimum age for consent which differs across the five study countries)

·         Female sex workers (FSW) and women engaging in transactional sex

·         Cisgender women aged 25 years and above

·         Transgender women

·         Transgender men and gender diverse persons who were assigned female at birth

·         Pregnant and breastfeeding populations (PBFP)

Team members: Robinson Karuga, Milicent Kiruki, Patricia Jeckonia, Linet Okoth  Link to researcher profiles

Research partners: FHI 360, NASCOP, USAID Kenya Mission. USAID Boresha Jamii USAIDxxx.

Funder: USAID

Links to publications: Work in progress


Assessing the acceptability and usability of microarray patches as a delivery system of HIV pre-exposure prophylaxis (PrEP) and as a multipurpose prevention technology (MPT) to protect from both HIV and unintended pregnancy among adolescents and young people


Kenya implements public health interventions to curb both HIV transmission and unintended pregnancies, a number of barriers have been noted including concerns about adherence, stigma and distrust from partners, unsupportive facility infrastructure, stigma and discrimination and negative partner influences. These barriers to compliance with PrEP and contraception may be addressed through technologies that facilitate discreet use and possibly self-administration. The microarray patch (MAP) is one such technology being developed. There is global interest in developing micro-array patches as an alternative delivery system for various drugs, including as a multi-purpose prevention technology (MPT) to reduce risk of HIV and unintended pregnancy. While MAPs are still in nascent stages of development, there is need to explore the potential programmatic fit of MAP technology for these indications, and to assess the usability and potential acceptability of MAPs for HIV PrEP and as an MPT among users and other stakeholders to inform development of these products.

This study aims to (a) explore the acceptability of MAP technology for HIV PrEP and an MPT among end users (b) explore usability of MAP prototypes among end users and providers who may be interested in HIV PrEP or an MPT and; (c) assess the programmatic fit of MAP technology for HIV PrEP and as an MPT among policy makers and program implementers. The study adopted a descriptive exploratory design. The research involves conducting mock user exercises with potential users and health service providers and traditional qualitative research methods.

Team members: Anne Ngunjiri, Sammy Gachigua, Robinson Karuga  Link to researcher profiles

Research partners: PATH

Funder: BMGF and USAID

Links to publications: Work in progress

Normative costing and willingness to pay study on the dapivirine vaginal ring in Kenya


In Kenya women are disproportionately affected by HIV and AIDS. Dapivirine ring (DVR) is an innovative intervention with potential to reduce HIV risk among women while increasing their choices in HIV prevention. The European Medicine Agency has issued a positive scientific opinion on DVR and WHO has issued a prequalification for it, confirming that it meets global standards for quality, safety and efficacy. DVR is currently awaiting Kenya regulatory approvals for its use.

Our study seeks to inform the development of a national costed implementation plan to support DRV introduction. The study objectives were; a) to determine the normative unit costs of providing the DVR by type of service delivery model (NGO, private, and public health facilities) for young women (aged 18-24), FSWs, and women over age 24 seeking health services (e.g. HIV prevention and family planning), in two regions of Kenya; b) to determine the amount that potential clients are willing to pay for dapivirine ring services; and, to understand the perspective of stakeholders regarding introduction and financing of the dapivirine ring and injectable cabotegravir.

Mixed methods cross-sectional study with costing component, willingness to pay survey and key informant interviews with stakeholders. The study populations include: 480 women and female sex workers who are potential ring clients; and 15-20 key informants from public and private sectors, non-governmental organizations (NGOs), and civil society.

Team members: Millicent Kiruki Link to researcher profiles

Research partners: FHI360

Funder: USAID

Links to publications:

Factors affecting access and Uptake of HIV, SRH, GBV information and services among Youth and Adolescents in Kenya: A Qualitative Study


Adolescents and young people (AYP), (10-19 and 20-24 years respectively) constitute 18% and 26% of the global population. This population subset in Kenya and Uganda is affected more by low access and uptake of HIV, GBV and SRH services in public health facilities.

This study sought to identify the facilitators and barriers to access and uptake these services in the two countries. We conducted this research in three counties in Kenya (Mombasa, Homabay and Nairobi) and 2 districts in Uganda (Busia and Luwero) during a 3-month period. The study adopted an exploratory qualitative approach, specifically using FGDs, IDIs and KII interviews to collect data.

Our findings showed that the facilitators for the access and uptake of HIV, GBV and SHRC included provision of AYP friendly services; availability of AYP friendly health service providers; availability of free HIV, SRH and GBV services; and availability of policies and guidelines related to HIV, GBV and SRH health service provision in Kenya and Uganda. The barriers affecting the access and uptake of these services in both countries included stigma (from self and others); unfriendly health service providers; long queues in public health facilities; having specially designated delivery points to these services, separate from other health service exacerbated stigma associated with the services; additionally, lack of commodities related to HIV, SRH and GBV services and poor implementation of policies and guidelines.

The study recommended the redress of the barriers that perpetuate the poor access and uptake of HIV, SRH and GBV services among the AYP such as ensuring availability of such services, training of health service providers on AYP specific concerns investing in community awareness to address the negative norms, myths and misconceptions that perpetuate stigma that negative affects these services access and uptake.

Team members: Patricia Jeckonia, Robinson Karuga Link to researcher profiles

Research partners: Africa Population Health Research Council, SDI-Kenya, LSTM

Funder: Frontline AIDS

An evaluation of the quality comprehensiveness of services and interventions provided through Project DARAJA


The LVCT Health-Daraja was a five-year HIV prevention project that was implemented between 2016 and 2021. It aimed to increase and scale up access to, and availability of sustainable, high quality, comprehensive HIV prevention interventions primarily for Key Populations (KP) – Men who have sex with other men (MSM), Female Sex Workers (FSW), and People who Inject Drugs (PWID) – and Adolescent Girls and Young Women (AGYW) in Kiambu and Nairobi Counties.

The study employed a cross-sectional design using mixed methods in 16 LVCT Health-Daraja sites. Quantitative data was abstracted from project Electronic Medical Records and subjected to descriptive and binomial analysis using Stata 17 in order to measure the uptake of HIV prevention and care services. 51 face-to-face in-depth interviews (IDI) with health workers and project beneficiaries and 6 key informant interviews (KIIs) with program managers and purposively sampled participants in 8 DiCEs and 8 DREAMS safe spaces in Nairobi and Kiambu Counties.

Key findings included:

1.    The targeted outreach was significantly more effective in identifying new HIV-positive FSW clients, with social network services SNS approach identified more HIV positive MSM and FSW clients.

2.     KP clients reported that building strong relationships with health service providers would enhance retention in care and treatment programs.

3.    HIV-self testing (HIVST) using rapid test kits was useful for reaching KP, AGYW clients-who were not willing to take up HIV prevention services in project sites.

4.    Health service providers perceived the same-day linkage to care and treatment as the most effective strategy for ensuring immediate uptake of care and treatment services for newly diagnosed KP clients. A review of the KP Cohort registers revealed that there was a reduction in the proportion of KP clients that reported STIs while they were enrolled in the LVCT Health-Daraja HIV prevention project.

Conclusion: This end-term evaluation demonstrates that targeted-outreaches yielded a higher number of new HIV positive key population clients. This approach facilitated access to KPs that do not access HTS in static facilities. The same day linkage to care and treatment demonstrated effectiveness in enhancing uptake of care and treatment services, adherence to the ART program and retention.

Team members: Dr Lilian Otiso, Robinson Karuga, Dr Phillip Masaulo, Christian Ochieng Link to researcher profiles

Research partners: CDC


Links to publications:


Assessing Health Care Providers’ Knowledge, Attitudes, and Practices relevant to PrEP service provision in Kisumu, Homabay, Kitui and Nairobi Counties, Kenya


In Kenya, adolescent girls and young women (AGYW) bear the highest HIV burden amongst adolescents. Understanding Health Care Providers (HCPs) perspectives on PrEP provision to AGYW will be important in ensuring that they have access to HIV services.

Objectives to: (a) Evaluate providers’ familiarity and knowledge of PrEP’s effectiveness, safety, side-effects, eligibility criteria, screening, initiation and follow-up requirements; (b) Explore providers’ attitudes and beliefs towards PrEP delivery to target populations, with focus on AGYW (c) Explore providers’ views on whether it would be feasible and acceptable to add PrEP delivery to HIV and reproductive health services, based on their experiences delivering those services.

290 health care providers from 16 facilities in Nairobi, Kitui, Kisumu, Homabay counties were selected to participate in the study. This study employed a descriptive, cross-sectional mixed-methods study design that was implemented in two phases: quantitative data collection (February to March 2018 – 290 respondents) and qualitative data collection (September to October 2018 – 40 respondents). Quantitative data was analyzed using Stata v13 while qualitative data was managed and analyzed using NVivo 11.


1.    The providers included women (n=174, 60%) and men (n=116, 40%).

2.    Although 90% of the providers reported to know about oral PrEP, only 41% (n=119) reported to have received formal training on it.

3.    Most providers (n=210, 72%) reported willingness to offer PrEP services to AGYW although many preferred promoting abstinence and felt PrEP would promote promiscuity among unmarried AGYW.

4.    Most providers identified increased workload and inadequate supply of commodities and tools as challenges.

Conclusion: Provision of oral PrEP to AGYW requires building the capacity of providers through training that provides them with the needed knowledge and focuses on improving their attitudes.

Recommendation: Health care providers providing oral PrEP should receive regular training and one that focuses on improving attitudes towards use of PrEP by AGYW.

Team Members: Dr Wanjiru Mikoma, Dr Jordan Kyongo, Dr Lina Digolo, Anne Kioko, Michael Kiragu, Maryline Mireku and Patriciah Jeckonia- Link to research profiles

Research partners: LVCT Health

Funder: USAID

Links to publications

Endline evaluation of the STEPS project in Kisumu, Kisii, Homabay and Migori counties


LVCT Health implemented the Support Towards Expanded Prevention Services (STEPS) Project between October 2016 to September 2021 in four (4) counties in Western Kenya, namely: Kisumu, Kisii, Migori, and Homabay. The goal of the STEPS project was to scale up and deliver a package of comprehensive and quality combination HIV prevention interventions to Female Sex workers (FSW), men who have sex with men (MSM), People who inject drugs (PWID), transgender (TG), Adolescent Girls and Young Women (AGYW) and Fisher-folk (FF). Through the project, LVCT Health enrolled approximately 17,000 KP clients and 16,000 FF with HIV prevention services.


The purpose of this evaluation was to assess the uptake and outcomes of two innovative HIV testing services, namely, index testing and social network services (SNS). We utilized a mixed methods cross-sectional design. We conducted 69 in-depth interviews (IDI) with 13 Health Service Providers (HSP), 18 FSWs, 12 MSMs, 8 PWIDs, and 8 Fisher-folk, 10 program managers. We abstracted quantitative data on the uptake and outcome of HTS and SNS strategies from the Electronic Medical Record (EMR) databases that were used in routine service delivery in 11 Drop-in Centers (DiCES) across three counties.


Some lessons learnt and Key actions:

·         Innovative HTS interventions such as index testing and SNS demonstrated effectiveness and efficiency in identifying HIV positive persons that were not previously aware of their HIV status.

·         Provision of friendly, stigma-free services improves uptake of index testing and PNS.

·         HIV positivity rates and elicitation rates varied among the different age groups and target populations.

·         Stigma and poor client relations undermine identification of HIV positive persons, as well as linkage to care and treatment.

·         When scaling up HTS approaches such as SNS and index testing, granular analysis on HIV positivity rates by gender, age-groups and KP typology will inform target interventions that tailor HTS to clients with specific demographic characteristics.

Key take ways for Policy makers

a)    Incorporate SNS guidelines in the current national HIV Testing Services Guidelines.

b)    Develop and disseminate training manuals on the implementation of index testing and SNS among key populations to sensitize health workers and standardize delivery of these interventions.

Team members: Dr Lilian Otiso, Robinson Karuga, Dr Phillip Masaulo, Christian Ochieng Link to researcher profiles

Research partners: CDC


Links to publications: