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NCT Number: NCT06250504

Long-Acting HIV Pre-Exposure Prophylaxis Integrated With Sexual and Reproductive Health - cRCT

The goal of this hybrid (1a) Cluster Randomised Controlled Trial phase 3B trial is to evaluate the effectiveness and implementation of offering a choice of HIV Pre-Exposure Products (PrEP) through community-based sexual and reproductive health services, on PrEP uptake and retention, and population prevalence of sexually transmissible HIV amongst adolescents and young adults living in rural South Africa.

Researchers will compare adding the choice of long-acting PrEP, i.e. two monthly injectable cabotegravir (CAB LA) or dapiravine vaginal ring and HIV post exposure prophylaxis packs to daily oral PrEP integrated with community-based SRH in the 20 intervention clusters with standard of care (SoC), daily oral PrEP integrated with community-based SRH in the 20 control clusters, on uptake and retention on PrEP. We hypothesise that offering a choice of long-acting or oral PrEP and PEP within the community-based delivery of SRH services will overcome the challenges and barriers to effective use of oral daily PrEP and lead to a population-level effect on uptake and retention on PrEP and thus the prevalence of sexually transmissible HIV amongst 15-30 year olds living in rural KwaZulu-Natal, South Africa.

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Key information

Conditions

HIV Infections Blood-Borne Infections Communicable Diseases Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

15 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Africa Health Research Institute

Somkele, KwaZulu-Natal, South Africa

Location status: Recruiting

Location contact

Maryam Shahmanesh, PhD

CONTACT

[email protected]

About this study

This is a pragmatic trial of adding in a choice of South African Health Products Registration Authority (SAHPRA) approved newer PrEP products - APRETUDE (cabotegravir) 600 mg\\3 mL: DAPIRING (Dapivirine) 25mg Vaginal Ring:56/20.2.8/0979 (22/11/2022) - to the current national department of health approved oral daily PrEP with TVF/FTC (Tenofovir disoproxil/emtricitabine), Objective 1. To measure the effectiveness of the choice of oral and long-acting PrEP, including injectable (CAB LA) and vaginal ring (DapiRing), and post exposure prophylaxis (PEP) on increasing effective uptake (adoption), retention, and adherence of PrEP compared to oral PrEP in young people aged 15-30 in rural South Africa and to estimate the preliminary effect on transmissible HIV and HIV incidence.

Objective 2. To understand real-world implementation:

2.1 To explore the acceptability, appropriateness, preference, and reach of CABLA from the perspective of young people aged 15-30 and their communities in rural South Africa 2.2 To understand the feasibility, affordability, and scalability of delivering CABLA through community-based PrEP with SRH.

2.3 To identify implementation challenges and practical solutions for CABLA initiation, laboratory monitoring (e.g. RNA testing), and safe stopping within nurse-led and rural community-based clinical settings 2.4 To evaluate the safety and tolerability of CABLA compared to oral PrEP

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

All young men and women aged 15-30 who are residing in the 40 administrative clusters in the study district and attend any integrated SRH/HIV service

Documented HIV negative test

Suitable for PrEP and/or already on PrEP

Weight > 35 kg

Understand the required dosing schedule and HIV testing.

Aware that details can be shared with a peer navigator to support their follow-up

If pregnant or breast feeding and/or planning to become pregnant participant can be offered CAB LA, if risk of acquiring HIV out weighs unknown risk of CAB LA, but must understand that safety in pregnancy or breast feeding for CAB LA has not been established and oral daily PrEP is a safe alternative.

Exclusion criteria

History or presence of allergy to the study drugs or their components

Investigator assessment find them not suitable

Additional exclusion criteria for specific products:

CAB LA: Taking medication that is contraindicated (Carbamazepine, oxcarbazepine, phenobarbital, phenytoin, Rifampin, rifapentine) and Severe mental health disorder, Hep B surface antigen positive, living with hepatitis C and not yet treated, or abnormal liver function tests (ALT more than two times the upper limit of normal)

DapiRing: Pregnancy.

Treatment and study plan

APRETUDE (cabotegravir) 600 mg\3 mL

Drug

choice of 2-monthly injectable long acting cabotegravir. The initial visit will be followed by planned visit for the first injection, one month visit for second injection, and then 2-monthly CAB LA injections with repeat HIV testing and pregnancy testing, and referral to peer navigators for adherence and retention support. We will conduct HIV testing, STI testing, Hep B, Hep C, and safety bloods (Full Blood Count, Creatinine, Liver Function Tests) at baseline, HIV testing two monthly, and annual safety bloods, alongside annual STI testing.

DAPIRING (Dapivirine) 25mg Vaginal Ring

Drug

The initial visit is followed by a 7-day phone call, 3-monthly follow-up. Each follow-up will include repeat HIV testing (POCT x2 and dry blood spots for HIV ELISA) and pregnancy testing, syndromic management of STIs, and referral to peer navigators for adherence support and PrEP/ART and if applicable contraception refills. Safely bloods (full blood count, creatinine, liver function tests) will follow national guidelines. Currently we aim to do baseline and annual safety bloods, alongside annual STI testing

tenofovir disoproxil and emtricitabine

Drug

The initial visit is followed by a 7-day phone call, 3-monthly follow-up. Each follow-up will include repeat HIV testing (POCT x2 and dry blood spots for HIV ELISA) and pregnancy testing, syndromic management of STIs, and referral to peer navigators for adherence support and PrEP/ART and if applicable contraception refills. Safely bloods (full blood count, creatinine, liver function tests) will follow national guidelines. Currently we aim to do baseline and annual safety bloods, alongside annual STI testing

Tenofovir Disoproxil, Lamuvidine and Dolutegravir

Drug

The initial visit is followed by a 7-day phone call, 3-monthly follow-up. Each follow-up will include repeat HIV testing (POCT x2 and dry blood spots for HIV ELISA) and pregnancy testing, syndromic management of STIs, and referral to peer navigators for adherence support and PrEP/ART and if applicable contraception refills. Safely bloods (full blood count, creatinine, liver function tests) will follow national guidelines. Currently we aim to do baseline and annual safety bloods, alongside annual STI testing

Primary outcomes

  1. Uptake PrEP

    Time frame: Through duration of trial, and up to 20 months

    Defined as the proportion of all young people (aged 15-30) residing in the trial area (the 40 clusters) who have received any PrEP (oral, injectable, ring, or PEP) through study-linked clinics

  2. Retention on PrEP

    Time frame: 14 months

    Defined as the proportion of participants enrolled at least 4 months before the end of the trial, attending at least one follow-up appointment after PrEP/PEP initiation.

Secondary outcomes

  1. The prevalence of transmissible HIV.

    Time frame: 14 months

    We will measure this outcome as the proportion of those living with HIV and have a detectable HIV viral load, defined as having an HIV viral load of >= 400 copies per ml, during our final survey round.

  2. Uptake of risk informed HIV prevention

    Time frame: 14 months

    Defined as the proportion of 15-30 year olds who are aware of their HIV status and are either on PrEP, if HIV negative, or are on antiretroviral therapy if living with HIV, during final survey round.

  3. Uptake of contraception

    Time frame: 14 months

    Proportion of women aged 15-30 who report currently using any contraception during final survey round

  4. Teenage Pregnancy

    Time frame: 14 months

    Proportion of adolescent girls aged 15-19 years who self-report currently being pregnant in the final survey round.

  5. Curable Sexually Transmitted Infections

    Time frame: 14 months

    Prevalence of any curable STIs is defined as the proportion of participants who test positive for at least one of the following infections: Chlamydia trachomatis (CT) or Neisseria gonorrhoeae (NG), based on Cepheid GeneXpert CT/NG testing measured in the final survey round

  6. Voluntary male medical circumcision (VMMC)

    Time frame: 14 months

    Proportion of male participants who report ever having undergone circumcision in the final survey round

  7. Proportion of men and women aged 16-30 at risk of acquiring HIV or transmitting HIV

    Time frame: 14 months

    If living with HIV (a detectable viral load + condomless sex + not on ART), or, if not living with HIV (condomless sex + not on PrEP)

  8. HIV incidence

    Time frame: 14 months

    The rate of new infections in the PrEP cohort irrespective of PrEP use

  9. Recent HIV infection using recency assays

    Time frame: 14 months

    Proportion of those living with HIV in the end-line survey with a positive recency assay on DBS

  10. improved mental health

    Time frame: 14 months

    Proportion with PHQ9 score consistent with common mental disorder in each arm

  11. PrEP Reach (Adoption)

    Time frame: 14 months

    Proportion of those at greatest risk adopting (taking up) PrEP or PEP in each arm. Greatest risk is defined as an aggregate exposure disaggregated by gender that includes any of the following factors: out of school (aged <= 18) or unemployed (aged >18) and/or engaged in transactional sex or sex work and/or harmful alcohol use (AUDIT scale) and/or experience physical, sexual or emotional violence (validated tool) and/or food poverty (recent experience of hunger)

  12. Adverse events

    Time frame: 14 months

    frequency and severity of adverse events associated with CABLA compared to oral PrEP.

  13. PrEP delivery cost and cost-effectiveness

    Time frame: 14 months

    cost per effective PrEP uptake in each arm

  14. Patterns of PrEP/PEP use

    Time frame: 14 months

    Longitudinal patterns of PrEP and PEP initiation, switching and stopping within the choice arm

Other outcomes

  1. Improved socioeconomic outcomes

    Time frame: 14 months

    Defined as proportion in school (aged <= 18) or unemployed (aged >18) and/or food secure (no recent experience of hunger) in each arm.

Study contacts

Contact information is provided by the study sponsor or research team.

Limakatso Lebina, MBBS PhD

CONTACT

[email protected]

Maryam G Shahmanesh, MBBChir PhD

CONTACT

[email protected]

+447776185572

Sponsors and collaborators

Lead sponsor

Africa Health Research Institute

Other

Registry information

Official study title

Long-acting HIV Pre-Exposure Prophylaxis Integrated With Community-based Sexual and Reproductive Health in South Africa (LAPIS): A Hybrid (1a) Cluster Randomised Controlled Phase 3B Trial of Effectiveness and Implementation

Acronym: LAPIS

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Feb 9, 2024
Registry last updated
Jul 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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