Full Project Name: Population Impact and Cost Effectiveness of Accelerating Community-Centred Equitable Lenacapavir for Key and Priority Populations in South Africa
Project Acronym (if applicable): N/A
Project Duration (Start – End Date):
Project Status (Ongoing / Completed / Upcoming): Ongoing
2. Project Overview
The LEN study (Lenacapavir study), embedded within the USINGA HDSS platform, is a population-based HIV prevention study focused on evaluating the rollout and impact of long-acting injectable lenacapavir in high-risk populations. It is implemented in Umlazi as part of broader efforts to strengthen HIV prevention strategies in South Africa. The study specifically targets adolescent girls and young women (AGYW) and other key populations such as sex workers, men who have sex with men (MSM), transgender women (TGW), and people who inject drugs (PWID). These groups are disproportionately affected by HIV and often face barriers to accessing consistent prevention services.
A central aim of the LEN study is to support the Department of Health’s rollout of twice-yearly injectable lenacapavir, a long-acting HIV prevention option. The study incorporates peer-led community mobilisation strategies to improve awareness, uptake, and accessibility of this intervention through community-based delivery sites.
Using the existing USINGA surveillance system, the study is able to track participants over time and assess outcomes at both individual and population levels. This includes measuring:
- Uptake and coverage of lenacapavir
- Adherence to the intervention
- HIV incidence and prevention outcomes
- Cost-effectiveness of large-scale implementation
The LEN study also benefits from data linkage within the HDSS, allowing researchers to combine clinical, behavioural, and socio-economic data to better understand the determinants of HIV risk and prevention success.
The LEN study mainly benefits people at highest risk of HIV, while also helping communities, the health system, and policy-makers make better decisions to reduce HIV infections and improve public health outcomes.
Ultimately, the LEN study aims to generate real-world evidence on the effectiveness of long-acting HIV prevention strategies. The findings are expected to inform national HIV programmes, policy decisions, and future scale-up strategies, contributing to efforts to reduce HIV transmission and improve health outcomes in vulnerable communities.
3. Background and Rationale
South Africa continues to face significant challenges related to health inequities, poor service delivery, and socio-economic disparities, particularly in densely populated urban townships. Umlazi, one of the largest townships in the country, represents a unique context where health outcomes are shaped by a complex interplay of social, environmental, and economic determinants. Despite its size and significance, Umlazi remains underrepresented in national population health data systems.
The Umlazi Surveillance Initiative to Nurture Grassroots Action (USINGA) was established to address this gap by generating robust, longitudinal data on health, socio-economic conditions, and population dynamics in the Umlazi community. As part of the South African Population Research Infrastructure Network (SAPRIN), USINGA contributes to a national effort to provide timely, high-quality data that can inform public health policy, social programming, and resource allocation.
4. Objectives
- Measure the population-level PrEP and LEN coverage following peer-led mobilization into community-based HIV and SRH services for AGYW and KPs.
- To evaluate the population-level changes in HIV incidence following peer-led mobilization into community-based HIV/SRH services for AGYW and KPs
- To describe the reach, adoption and implementation of LEN delivered through community and civil society engagement and peer-led mobilisation into community-based HIV/SRH services.
- To characterise uptake and persistence on LEN across population groups, gender, age and geographical settings to identify inequities in access.
- To assess the effect of community and civil society engagement/peer-led mobilisation into community-delivery venues on uptake of HIV testing and SRH.
- To evaluate cost, cost-effectiveness and scalability of peer-led mobilisation into community-delivery sites within the NDoH domestically funded LEN scale-up
5. Study Setting and Population
The USINGA HDSS is nested in Umlazi, specifically Ward 79, 82 and the newly added ward, Ward 88. Umlazi is a township in eThekwini, with a population of approximately 404 811 people in 104 914 households, covering an area of 47.5 km². Umlazi has a mixture of formal and informal residences. Umlazi has a young population, as approximately 71.2% of the population is in the economically active age group, although unemployment is high, with 65% employed, accounting for 54 000 men and 43 000 women. Many households reported that they do not have a regular income (30%). There are high levels of informal activity in the area to attain survival. Most of the income-earning households are in the low range of R4 801 – R9 600 (14.2%), R9 601 – R19 200 (17%), and R19 201 – R38 400 (16.2%).
Reflecting the population in Umlazi, the USINGA DSA population is composed of 47% males and 53% females, with the majority of residents in the working-age group (15–64 years) and a substantial proportion between the ages of 25–34 years. The majority of the population are not married.
The population’s socio-economic profile is further reflected in social grant receipt patterns. Although 63.8% report not receiving any grant, the Child Support Grant is the most common (received by 58.0% of recipients), followed by the Social Relief of Distress Grant (17.8%). Regarding educational attainment, 45.2% have completed Grade 12, while 21.7% have attained tertiary-level education.
6. Methodology
Participatory workshops
The study will conduct 4-5 workshops with the district Department of Health PrEP implementation working group (one at the beginning and one at the end), one with clinical teams; one with the implementing teams, and one with community groups. Using participatory research methods such as facilitated discussions, listing and ranking to describe the key ingredients and trade-offs from provider and user perspectives of an effective integration of services to:
- Optimise the integration of Lenacapavir delivery within the different community hubs
- The minimum information and format to be electronically shared from the community hubs with the primary care clinics.
Quantitative data collection
AHRI and Umlazi HDSS conduct individual biobehavioural surveys annually, this project will add specific questions around PrEP modalities. The study also offers point of care HIV testing and dry blood spots for HIV ELISA and viral load, comparing baseline with annual surveys. The study will use two RDS surveys (before and after). It will also collect routine programme data (to measure number that test for HIV and number who are newly start ART or newly start any PrEP/PEP and uptake and retention on Lenacapavir by risk).
Qualitative data collection
Rapid ethnographic surveys
The rapid ethnographic assessment will be conducted during two time points: The first before Len roll out and the second after Len roll out in five communities across the study sites. The study will use a set of participatory methods, including transect/spiral walks, observations, conversations, in-depth interviews and group discussions with community members, stakeholders such as health service providers and young people. The rapid ethnographic assessment will be conducted twice over the during the course of the study, once at the beginning and once at
the end to allow us to document changes in service experience and reach before and after integration.
Service providers:
During rollout, the study will use observations, natural group discussions, and short one-on-one informal conversations with implementers, along with semi-structured interviews of n=20 with nurses in mobile clinics and primary health care services, HIV counsellors (CRAs), and outreach workers. Semi-structured interviews will be conducted with n=10 nurses/clinical research assistants; and n=10 peer-navigators/outreach workers. Social scientists will also participate in team training and supervision, holding regular debriefs to explore perceptions and experiences of service integration.
Service users:
The study will conduct semi-structured interviews with a qualitative cohort of n=30 service users, purposive sampling will be used to include both those who access clinical services and those who do not. A timeline type diary tool will be used to facilitate monthly oral check-ins with the participants, helping to explore their journey and experiences as they navigate services.
7. Partnerships and Collaborators
The LEN study is implemented through a multi-sectoral collaboration involving academic institutions, implementing organisations, government stakeholders, and community structures to ensure effective delivery and impact.
Academic Partners
The study is led and supported by academic and research institutions, including:
- The University of KwaZulu-Natal (UKZN)
- The South African Population Research Infrastructure Network (SAPRIN)
These partners provide scientific leadership, research design, data analysis, and dissemination of findings.
Implementing Partners
Implementation is supported by organisations involved in HIV prevention and community-based service delivery, such as:
- The South African Medical Research Council (SAMRC)
- Local non-governmental organisations (NGOs) and community-based organisations
They are responsible for programme rollout, community engagement, peer-led interventions, and service delivery support.
Government Departments
The study works closely with:
- The South African National Department of Health
- The KwaZulu-Natal Department of Health
These departments support policy alignment, integration into public health systems, and scale-up of lenacapavir as part of HIV prevention strategies.
Community Structures
Community involvement is central to the LEN study and includes:
- Community Advisory Boards (CABs)
- Local leaders and stakeholders within Umlazi
8. Community Engagement
Community involvement is a central component of the LEN study, ensuring that the research remains ethical, culturally appropriate, and responsive to local needs. A key structure supporting this is the Community Advisory Board (CAB), which consists of local representatives and stakeholders who provide input on study design and implementation, advise on ethical considerations, and help ensure that the study is acceptable within the community. In addition, the study conducts regular community dialogues, stakeholder meetings, and consultations to create platforms for open engagement, raise awareness about HIV prevention and lenacapavir, and align the project with community priorities.
The study also prioritises transparency through ongoing feedback and dissemination activities, including community report-back sessions and sharing findings in accessible formats and local languages such as isiZulu. This helps build trust and encourages community ownership of the research. Furthermore, the LEN study creates local employment opportunities by recruiting and training community members as fieldworkers, peer educators, and data collectors, thereby contributing to skills development and economic empowerment. Overall, the study adopts a participatory approach in which the community plays an active and meaningful role throughout the research process.
9. Ethical Approval
Name of Ethics Committee: BREC University of KwaZulu-Natal
Approval Number: BREC/00004934/2022
Consent Procedures: Written consent and assent procedures
Confidentiality and Data Protection Measures: De-identified data, secure systems, POPIA compliant
10. Outputs and Impact
-Publications (if available)
-Reports or Policy Briefs
-Conference Presentations
-Expected Outputs (if ongoing)
-Policy or Community Impact
11. Data Access (if applicable)
Is data available for external researchers? (Yes/No)
Data Access Process:
Link to Data Access Policy:
Contact Email:
12. Project Team (Please provide head shots as well)
Principal Investigator
Co-Investigators
Project Manager
Field Coordinator
Key Staff
13. Contact Information
Project Email:
Social media platforms:
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Website link (if applicable):
14. Visual Content (Optional for Website Use)
-Maps of Study Area
-Infographics
-Photographs (with consent)
-Project Timeline