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

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.

Start Date27 Feb 2024

Sponsor / Collaborator-

NCT06807736

/ RecruitingNot ApplicableIIT

PrEPared to Choose (PtC): An Implementation Study of the Delivery of Cabotegravir Long-acting Injectable Pre-exposure Prophylaxis (PrEP) as an HIV Prevention Product Option Within a PrEP Choice Context in a Real World Setting in Cape Town.

The goal of this clinical trial is to offer adolescents and young people in Cape Town, South Africa different HIV pre-exposure prophylaxis (PrEP) products and describe how they use these products over an 18-month period. The study has both clinical and implementation primary aims. The primary clinical aim is short and long-term persistence on PrEP. Persistence is defined as the length of time that a participant shows continuous use of a PrEP product as intended, without stopping PrEP or switching to another PrEP product. The primary implementation aim involves the determination of factors that either enable or serve as a barrier to PrEP uptake and continuation.
Participants will be offered a choice between three antiretroviral-containing PrEP products: (1) a Tenofovir-based oral tablet that needs to be taken daily; (2) a vaginal ring containing Dapivirine that provides HIV protection for up to one month; and (3) an intramuscular injection containing Cabotegravir that provides HIV protection for up to two months. Participants will be able to use the same product throughout the study, switch between products, or stop and restart on PrEP at any point.
The study will be offered from two study sites: the first is a mobile clinic that rotates on a fixed schedule across the study area and the second is a fixed-location government primary healthcare clinic. The study will be open to confirmed HIV-negative individuals, including adolescent girls and young women (aged 15-29 years), young gender and sexually diverse populations aged 15-29 years (including men who have sex with men, transgender people, and non-binary people), and their collective sexual partners (including heterosexual, cisgender men) of any age.

Start Date13 Feb 2024

Sponsor / Collaborator

Desmond Tutu Hiv Foundation

[+2]

NCT05416021

/ CompletedPhase 1

A Phase I, Open-Label, Randomized, Crossover Trial to Investigate the Relative Bioavailability of the 25 mg Dapivirine Vaginal Ring-004 Inserted Every 30 Days and 100 mg DPV Ring-008 Inserted for 90 Days in Healthy Female Participants

A Phase I, Open-Label, Randomized, Crossover Trial to Investigate the Relative Bioavailability of the 25 mg Dapivirine Vaginal Ring-004 inserted every 30 days and 100 mg Dapivirine Vaginal Ring-008 inserted for 90 days in Healthy Female Participants

Start Date01 Aug 2022

Sponsor / Collaborator

INC Research Holdings, Inc.

100 Clinical Results associated with Dapivirine

100 Translational Medicine associated with Dapivirine

100 Patents (Medical) associated with Dapivirine

271

Literatures (Medical) associated with Dapivirine

11 Jun 2026·CLINICAL MICROBIOLOGY REVIEWS

Interactions between long-acting antiretrovirals and opioids: a call for clinical awareness

Review

Author: El-Hage, Nazira ; Fernandez-Lima, Francisco ; Owens, Florida ; Carbajal, Candy ; Veeragoni, Dileepkumar ; Nefzi, Adel ; Buch, Shilpa ; Rodriguez, Myosotys

SUMMARY:

This review summarizes potential drug-drug interactions (DDIs) between long-acting antiretrovirals (LAAs) and opioids, focusing on pharmacodynamics (PD), pharmacokinetics (PK), and side effects related to absorption, distribution, metabolism, and excretion (ADME). It also covers dysregulation in epigenetics and in the immune system. A comprehensive literature review was performed using PubMed and Google Scholar, along with data from the Liverpool HIV Drug Interactions Database, to evaluate pharmacokinetic interactions between LAA drugs, such as cabotegravir, rilpivirine, lenacapavir, and dapivirine, with opioids used in clinical settings, including morphine, tramadol, oxycodone, and codeine; medications for opioid use disorder (MOUD), such as methadone and buprenorphine; and the illicit opioids, including fentanyl and heroin. The review highlights key factors increasing DDI risk and discusses clinical considerations for managing preexposure prophylaxis (PrEP) or antiretroviral therapy (ART) in persons who use opioids. Lastly, it proposes research strategies for studying DDIs, including the use of animal models, physiologically based pharmacokinetic (PBPK) models, and clinical trials.

02 Jun 2026·Open Forum Infectious Diseases

Vaginal Microbiota and Cytokines Among Pregnant and Breastfeeding Women in Clinical Trials of the Dapivirine Vaginal Ring and Oral Tenofovir Disoproxil Fumarate/Emtricitabine

Article

Author: Fairlie, Lee ; Hillier, Sharon L ; Bunge, Katherine ; Beamer, May ; Mhlanga, Felix ; Brown, Elizabeth R ; Noguchi, Lisa M ; Dong, Tracy Q ; Piper, Jeanna ; Balkus, Jennifer E ; Petrina, Melinda A B

Abstract:

Background:

Vaginal dysbiosis is associated with HIV acquisition and preterm delivery. Our objective was to evaluate prevalent vaginal infections, and changes in microbiota and cytokines among pregnant and breastfeeding women from 4 African countries using dapivirine vaginal ring (DVR) or oral tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) in 2 parallel nonoverlapping trials.

Methods:

MTN-042 (NCT03965923) was a randomized trial evaluating daily TDF/FTC or monthly DVR during pregnancy (n = 558), and MTN-043 (NCT04140266) was a randomized study evaluating TDF/FTC or DVR during breastfeeding (n = 197). Women were evaluated for vaginal infections at enrollment and follow-up using Nugent score and BD Max™ Vaginal Panel. Microbiota was evaluated by quantitative PCR for 12 bacterial targets; 5 cytokines and RANTES were evaluated by MAGPIX. Rates of change in vaginal microbiota and cytokines and prevalence of vaginal infections were evaluated using generalized linear mixed models and Benjamini–Hochberg (BH)-adjusted P values.

Results:

Vaginal infections, microbiota and cytokines did not differ between the 2 study arms at baseline. Lactobacillus crispatus was less frequently detected postpartum and during breastfeeding compared with pregnancy. Bacterial vaginosis (BV) and Candida were common during pregnancy and breastfeeding, but there was no significant difference in the rate of change in these infections by study arm. BV-associated microbiota and cytokines changed over pregnancy and postpartum, but the rate of change by study arm did not differ.

Conclusions:

Vaginal infections, microbiota or cytokines/chemokines changes were similar in women using DVR or TDF/FTC. These data augment the robust safety profile for DVR to support its use during pregnancy and breastfeeding.

01 Jun 2026·JAIDS-JOURNAL OF ACQUIRED IMMUNE DEFICIENCY SYNDROMES

Comment on “Higher Acceptability of the Monthly Dapivirine Ring versus Daily Oral Pre-exposure Prophylaxis Among Adolescent Girls and Young Women in Sub-Saharan Africa in the REACH Trial”

Article

Author: Sah, Shyam Sundar ; Kumbhalwar, Abhishek

News (Medical) associated with Dapivirine

19 May 2026

·www.cidrz.org

CIDRZ CHEP Pays Courtesy Call on Central Province Health Office During Lenacapavir Training in Kabwe.

CIDRZ’s Controlling HIV Epidemic Project (CHEP) paid a courtesy call on the Central Province Health Office in Kabwe as part of ongoing activities related to the transitioning of the Zambia Integrated Health (ZIH) program, from Pact Inc. to CIDRZ. During the same period, CIDRZ, in collaboration with the Ministry of Health, is conducting a Trainer of Trainers (ToT) workshop focused on the rollout of pre-exposure prophylaxis (PrEP) products, namely, cabotegravir, Dapivirine Vaginal Ring (DVR) and Lenacapavir, a groundbreaking HIV prevention intervention described by experts as the closest alternative to an HIV vaccine. The PrEP workshop aims to equip frontline healthcare workers with the knowledge and skills required to effectively deliver the different PrEP products as Zambia strengthens efforts towards HIV epidemic control. The CHEP delegation was led by Ms Francheskie Vélez, Director of the Health Coordination Office at the U.S. Embassy in Zambia and included CHEP Chief of Party Dr Maurice Musheke. Speaking during the visit, Ms Vélez reaffirmed the U.S. Government’s commitment, through the U.S. Embassy in Zambia, to strengthening partnerships with local organisations to implement life-saving health interventions. She noted that CIDRZ had been identified as an ideal local partner as the U.S. Government shifts focus on prioritising local organisations to lead and sustain public health programmes. Ms Vélez also thanked the Provincial Health Office for hosting the team and supporting the successful implementation of the training programme in Kabwe. The Provincial Health Director, Dr Elijah Mutoloki, was represented by Dr Mwanja Kakusa, the Provincial Clinical Care Specialist for Central Province, who welcomed the delegation and expressed appreciation for selecting Kabwe as the host district for the training. Dr Kakusa noted that the Training of Trainers workshop was particularly important because Central Province had not been included in the previous training. She added that the healthcare workers participating in the training would play a critical role in cascading the knowledge and skills acquired to other healthcare workers across the province. Dr Kakusa further stated that the training would strengthen the province’s HIV response by enhancing healthcare workers’ capacity to deliver innovative HIV prevention services as the province seeks to achieve epidemic control. CIDRZ continues to work closely with the Ministry of Health, the U.S. Government through the U.S. Embassy in Zambia, and other partners to support evidence-based interventions that improve health outcomes and advance Zambia’s HIV response.

Clinical Study

22 Apr 2026

·www.cidrz.org

CIDRZ, Ministry of Health Train HIV Specialists in Advanced PrEP Delivery to Strengthen Prevention Efforts.

To strengthen HIV prevention efforts, the Controlling HIV Epidemic Project (CHEP), under the Centre for Infectious Disease Research in Zambia (CIDRZ), in collaboration with the Ministry of Health and with financial support from the United States Department of State, conducted a six-day Training of Trainers (ToT) workshop on the delivery of different pre-exposure prophylaxis (PrEP) products. The training which was held in Ndola, brought together HIV healthcare specialists from CIDRZ, the Copperbelt Provincial Health Office, Ndola Teaching Hospital, Copperbelt District Health Offices, and the United States Department of State. Participants were drawn from Eastern, Western, Lusaka, and Copperbelt provinces. The training was officially opened by Copperbelt Provincial Health Director, Dr Charles Mwinuna, and focused on equipping participants with the skills required to deliver combination HIV prevention services. Particular emphasis was placed on oral PrEP, Cabotegravir (2-month injectable PrEP), Lenacapavir (6-month injectable PrEP), and the Dapivirine Vaginal Ring (DVR), a long-acting, user-controlled PrEP product designed to reduce the risk of acquiring HIV during vaginal sex. Meanwhile, Dr Paul Mwale, Copperbelt Provincial Advanced HIV Disease (AHD) and Injectable PrEP Coordinator under the Ministry of Health, led a session outlining the mandate of the HIV Prevention Programme, which aims to achieve epidemic control and end AIDS by 2030. He highlighted national targets, including reducing new HIV infections from 28,000 to 15,000 by 2026 and increasing PrEP uptake among key and priority populations to 220,000 annually, emphasising the need for accelerated efforts to meet both national and global goals. In another session, Dr Monica Chibesakunda, CIDRZ’s HIV Testing and Prevention Lead, trained participants on HIV testing services, stressing their role in both preventing new infections and linking individuals to care. She emphasised adherence to national HIV testing guidelines for PrEP initiation and the importance of providing tailored prevention services based on individual risk. Other sessions covered demand generation for PrEP, scheduling PrEP clinical visits, managing beneficiaries who missed appointments, switching beneficiaries between PrEP products, pharmacovigilance, and comprehensive data documentation. The training also addressed the link between Gender-Based Violence (GBV), Intimate Partner Violence (IPV), and HIV risk. Facilitators underscored the importance of integrating GBV and IPV screening into HIV services to support comprehensive, client-centred care. The workshop concluded with participants committing to cascade the knowledge gained and strengthen HIV prevention services, contributing to Zambia’s goal of ending AIDS as a public health threat by 2030.

Clinical Study

18 Jan 2023

·pipelinereview.com

Janssen and Global Partners to Discontinue Phase 3 Mosaico HIV Vaccine Clinical Trial

Independent, scheduled review of Phase 3 Mosaico study finds investigational vaccine regimen lacks efficacy in preventing HIV No vaccine-related safety issues identified LEIDEN, THE NETHERLANDS I January 18, 2023 I The Janssen Pharmaceutical Companies of Johnson & Johnson, together with a consortium of global partners, today announced the results of an independent, scheduled data review of the Phase 3 Mosaico study (also known as HPX3002/HVTN706) of Janssen’s investigational HIV vaccine regimen. The study’s independent Data and Safety Monitoring Board (DSMB) determined that the regimen was not effective in preventing HIV infection compared to placebo among study participants. No safety issues with the vaccine regimen were identified. In light of the DSMB’s determination, the Mosaico clinical trial will be discontinued. Participant notifications and further analyses of the data are underway. Throughout the trial, study investigators have ensured that any individuals who contracted HIV received prompt HIV treatment and care. “We are disappointed with this outcome and stand in solidarity with the people and communities vulnerable to and affected by HIV,” said Penny Heaton, M.D., Global Therapeutic Area Head, Vaccines, Janssen Research & Development, LLC. “Though there have been significant advances in prevention since the beginning of the global epidemic, 1.5 million people acquired HIV in 2021 alone, underscoring the high unmet need for new options and why we have long worked to tackle this global health challenge. We remain steadfast in our commitment to advancing innovation in HIV, and we hope the data from Mosaico will provide insights for future efforts to develop a safe and effective vaccine. We are grateful to our Mosaico partners and the study investigators, staff and participants.” About the Phase 3 Mosaico Study Mosaico, a Phase 3 study of Janssen’s investigational HIV vaccine regimen, began in 2019, and completed vaccinations in October 2022. The study included approximately 3,900 cisgender men and transgender people who have sex with cisgender men and/or transgender people, who represent groups and populations vulnerable to HIV, at over 50 trial sites in Argentina, Brazil, Italy, Mexico, Peru, Poland, Puerto Rico, Spain and the United States. The study evaluated an investigational vaccine regimen containing a mosaic-based adenovirus serotype 26 vector (Ad26.Mos4.HIV) administered during four vaccination visits over one year. A mix of soluble proteins (Clade C/Mosaic gp140, adjuvanted with aluminum phosphate) was also administered at visits three and four. The Mosaico DSMB analysis, based on the data available to date, indicated that the regimen does not protect against HIV and the study is not expected to meet its primary endpoint. No safety issues with the vaccine regimen were identified. In light of this, the study will be discontinued, and further analyses are underway. The DSMB’s determination follows the primary analysis of the Phase 2b Imbokodo study, which was announced in August 2021 and found that a similar investigational HIV vaccine regimen did not provide sufficient protection against HIV in a population of young women in sub-Saharan Africa. The investigational vaccine regimen used in the Imbokodo study was found to have a favorable safety profile. The Mosaico study was led by a global public-private partnership including the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), the HIV Vaccine Trials Network (HVTN), the U.S. Army Medical Research and Development Command (USAMRDC), and Janssen Vaccines & Prevention B.V. Since 2005, Janssen Vaccines & Prevention B.V. has been participating as a sub-grantee in the NIH-supported Integrated Preclinical/Clinical AIDS Vaccine Development (IPCAVD) program under grants AI066305, AI078526, AI096040 and AI128751 (Principal Investigator, Prof. Dan Barouch). Johnson & Johnson’s Commitment to HIV Johnson & Johnson has been committed to the fight against HIV for decades, playing a key role in bringing nine therapeutics to people living with HIV and continuing to drive innovation in HIV prevention and care. In January 2021, the dapivirine ring, a discreet long-acting HIV prevention method specifically developed for women by the International Partnership for Microbicides (IPM) and based on Janssen’s compound, was recommended by the World Health Organization as an additional prevention choice for women with a substantial chance of contracting HIV as part of combination prevention approaches. In July 2021 , Zimbabwe became the first country to approve the use of the dapivirine ring among women ages 18 and older, with South Africa following suit in March 2022 . Additional regulatory decisions are pending. Johnson & Johnson also works with vulnerable communities on the frontlines of the HIV epidemic, and has supported collaborative initiatives like the DREAMS Partnership in sub-Saharan Africa, the MenStar Coalition , and the New Horizons Collaborative . To learn more about Johnson & Johnson’s commitment to combatting HIV, please visit jnj.com/hiv . About Johnson & Johnson At Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities, and forward progress. That’s why for more than 135 years, we have aimed to keep people well at every age and every stage of life. Today, as the world’s largest diversified healthcare products company, we are committed to using our reach and size for good. We strive to improve access and affordability, create healthier communities, and put a healthy mind, body, and environment within reach of everyone, everywhere. We are blending our heart, science, and ingenuity to profoundly change the trajectory of health for humanity. About the Janssen Pharmaceutical Companies of Johnson & Johnson At Janssen, we’re creating a future where disease is a thing of the past. We’re the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular, Metabolism & Retina; Immunology; Infectious Diseases & Vaccines; Neuroscience; Oncology; and Pulmonary Hypertension. Learn more at http://www.janssen.com and follow us at http://www.twitter.com/JanssenGlobal and www.twitter.com/JanssenUS . Janssen Vaccines & Prevention, B.V. and Janssen Research & Development, LLC are part of the Janssen Pharmaceutical Companies of Johnson & Johnson. SOURCE: Johnson & Johnson

VaccinePhase 2Phase 3Clinical Result

100 Deals associated with Dapivirine

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Indication	Highest Phase	Country/Location	Organization	Date
HIV Infections	Phase 3	Kenya	INC Research Holdings, Inc.	01 Jul 2011
HIV Infections	Phase 3	Kenya	International Partnership for Microbicides	01 Jul 2011
HIV Infections	Phase 3	Malawi	INC Research Holdings, Inc.	01 Jul 2011
HIV Infections	Phase 3	Rwanda	INC Research Holdings, Inc.	01 Jul 2011
HIV Infections	Phase 3	Rwanda	International Partnership for Microbicides	01 Jul 2011
HIV Infections	Phase 3	South Africa	INC Research Holdings, Inc.	01 Jul 2011
HIV Infections	Phase 3	Zimbabwe	INC Research Holdings, Inc.	01 Jul 2011
Acquired Immunodeficiency Syndrome	Phase 2	South Africa	International Partnership for Microbicides	01 Jul 2009
Acquired Immunodeficiency Syndrome	Phase 2	South Africa	INC Research Holdings, Inc.	01 Jul 2009
Contraception	Phase 1	United States	International Partnership for Microbicides	17 Jul 2018

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03965923 (MTN-042/DELIVER, Pubmed \| Lancet HIV)	Phase 3	HIV Infections	251	Dapivirine vaginal ring	ksbauwhkho(vojpaxkhvu) = rzsiatjbav okphvttoou (xfaxkjmnbd ) View more	Positive	01 Mar 2026
NCT03965923 (MTN-042/DELIVER, Pubmed \| Lancet HIV)	Phase 3	HIV Infections	545	Dapivirine vaginal ring	deywuxzotc(clgqzuvojf) = ivbaqqlggt snpdwiclev (ygllqrcfnf ) View more	Positive	01 Nov 2025
				Oral PrEP (tenofovir disoproxil fumarate plus emtricitabine)	deywuxzotc(clgqzuvojf) = znbnqsfghd snpdwiclev (ygllqrcfnf ) View more
NCT04140266 (MTN-043, Pubmed \| Lancet HIV)	Phase 3	Breast Feeding	197	Dapivirine vaginal ring (DVR)	iuwgfsbeyq(ghnahpdwap) = wuztjqkqhh ujpzbvrcff (iozsurjbzg )	Positive	01 Mar 2025
NCT01617096 (MTN-020/ASPIRE, Pubmed \| J Infect Dis)	Phase 3	HIV Infections	-	Dapivirine Vaginal Ring	wilvdcnqbz(vykmulbmrd) = dlrosbieco tnahfpuoaf (zztxubqpje, 1.8 - 3.1)	Positive	12 Apr 2024
				Placebo	wilvdcnqbz(vykmulbmrd) = pdbumamrkb tnahfpuoaf (zztxubqpje, 2.9 - 4.4)
NCT01539226 (The Ring Study, Pubmed \| BMJ Open) Manual	Not Applicable	HIV Infections	197	Dapivirine vaginal ring / placebo vaginal ring	qcrsdimmym(pxperagokw) = aiuxmtiwhf cjdqnibwlb (ovncxmhowt, 44.7 - 60.3) View more	Negative	08 Apr 2024
				Dapivirine vaginal ring	qcrsdimmym(pxperagokw) = gkbzirqrdn cjdqnibwlb (ovncxmhowt )
NCT01617096 (MTN-020/ASPIRE \| ASPIRE \| MTN-020, CTgov)	Phase 3	HIV Infections	2,629	Dapivirine Vaginal Ring (Dapivirine Vaginal Ring)	cjnxplbwpu = vyszzxoaof phtuyzifzx (izhmjisbjg, afthrunwop - jdgcctcpzu) View more	-	16 Dec 2022
				Placebo Ring (Placebo Ring)	cjnxplbwpu = egtckeqhyd phtuyzifzx (izhmjisbjg, phtomrmlfb - kbqbevekzf) View more
NCT02862171 \| NCT01539226 (The Ring Study and DREAM, Pubmed)	Phase 3	HIV Infections	-	Dapivirine Vaginal Ring-004 (DVR)	jzgaflkxgw(jtbblcgmvb) = zsxqbmnghe suuhwnpctt (hkjvevjdnw )	-	08 Nov 2022
NCT00799058 (CTgov)	Phase 1/2	HIV Infections	128	dapivirine gel 4759 (Dapivirine Gel 4759)	qxciqpebtv = jrftvxxxqa jrhgzhgsdf (edjwymwfty, mpcqrnmfah - izfghaferr) View more	-	25 Oct 2022
				dapivirine 4789 (Dapivirine Gel 4789)	qxciqpebtv = zjwrxelqhw jrhgzhgsdf (edjwymwfty, gmqbsfczxi - opnzeacunf) View more
NCT02862171 (DREAM, CTgov)	Phase 3	HIV Infections	941	Dapivirine Vaginal Ring-004	lebhzerauk = tpiuriclmp retrxdchmo (scvsyenqym, jiudlezzbz - avxdovwblp) View more	-	25 Oct 2022
NCT02858037 (HOPE, CTgov)	Phase 3	HIV Infections	1,456	Dapivirine Vaginal Ring	pcuihhzrml = ltlskbdouo syoureukbu (ueopmlivmb, smraoflrbz - hsdacxmwpk) View more	-	25 Oct 2022

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