Generating Knowledge - Impacting Health
CAPRISA Studies
Below is a list of CAPRISA studies. The protocols for each study can be accessed by clicking on the title of the study. Researchers wanting to access data from the completed CAPRISA studies are requested to complete a data request form. The form can be accessed here
| STUDY | ABBREVIATED TITLE |
TITLE | PRINCIPAL INVESTIGATOR/S |
TYPE OF STUDY |
| ONGOING | ||||
| CAP 012C | SAMBA trial III | A double-blinded, randomized, placebo-controlled phase II trial to assess extended safety and tolerability of subcutaneous CAP256V2LS and VRC07-523LS in HIV-negative women | Prof Salim Abdool Karim/ Prof Quarraisha Abdool Karim | |
| CAP 097 | TAF Implant | Dr Tanuja N. Gengiah | Cohort study | |
| CAP 002 |
Acute Infection Study |
Viral set point and clinical disease progression: the role of immunological, genetic and viral factors over the course of disease and during antiretroviral therapy | Prof Salim Abdool Karim | Observational |
| CAP 018 | TAF Implant | A phase I/II trial to assess the safety, acceptability and pharmacokinetics of a sustained-release tenofovir alafenamide sub-dermal implant for HIV prevention in women | Prof Salim Abdool Karim | RCT |
| CAP 020 | InDEX | Effectiveness of indivualized XDR-TB treatment study; a strategy to improve treatment outcomes in patients with XDR TB | Dr Nesri Padayatchi / Prof Kogie Naidoo |
RCT |
| CAP 022 | Broadly Neutralising Antibody |
CAP 012B - A Phase I Dose-Escalation Study of the Safety, Tolerability and Pharmacokinetics of a Human Monoclonal Antibody, CAP256V2LS (VRC-HIVMAB0102-00-AB) administered intravenously to HIV-negative and HIV-positive women or subcutaneously alone and in combination with VRC07-523LS and /or PGT121 to HIV-negative women in South Africa |
Prof Salim Abdool Karim | RCT |
| CAP 023 | Broadly Neutralising Antibody | CAP 012C - A double-blinded, randomized, placebo-controlled phase II trial to assess extended safety and tolerability of subcutaneous CAP256V2LS and VRC07-523LS in HIV-negative women | Prof Salim Abdool Karim | RCT |
| CAP 228 | Sub-study: A prospective cohort study to establish the association between COVID 19 and influenza on TB incidence, prevalence and severity | Prof Kogie Naidoo | Cohort Study | |
| CAP 090 | MIST Study | Mucosal Injury from Sexual Trauma: Understanding the Interaction Of Biology And Behaviour Of South African Adolescents | Dr Jo-Ann Passmore/ Heather Jaspan | Cohort Study |
| CAP 091 | STREAM 2 -HIV | Simplifying Treatment and Monitoring for HIV (STREAM HIV): Point-of-Care Urine Tenofovir Adherence and Viral Load Testing to Improve HIV Outcomes in South Africa | Dr Nigel Garrett /Dr Paul Drain |
RCT |
| CAP 093 | INSIGHT study | INSTI’s for the management of HIV-associated TB: A phase 2b study to evaluate the efficacy, safety and pharmacokinetics of a combination of Bictegravir, Emtricitabine, and Tenofovir Alafenamide Fumarate for treatment of HIV-1 infection in patients with drug-susceptible tuberculosis on a Rifampicin-based treatment regimen |
Dr Anushka Naidoo | |
| CAP 255 | POwER | POwER: Point Of care viral load testing to Enhance Re-suppression | Dr Nigel Garrett/ Dr Jiecheni Doward | |
| CAP 257 | PHILA | PHILA: Point of care HIV viral Load testing in a community ART programme | Dr Nigel Garrett / Dr Jiecheni Doward | |
| CAP 258 | ORCHID | Optimizing dolutegraviR dosing in TB co-infected CHIlDren | Dr Anushka Naidoo / Dr Moherndran Archary | Cohort Study |
| CAP 259 | SHAPE | STRENGTHENING HIV HEALTH SYSTEMS THROUGH AUDIT & PROGRAMMATIC DATA EVALUATION | Dr Jienchi Dorward / Dr Nigel Garrett | Observational |
| CAPRISA POLICY SUPPORT | CAPRISA POLICY SUPPORT: An initiative to provide high-quality evidence-based scientific advice to enhance South Africa’s epidemic policy- and decision-making | Prof Salim Abdool Karim | ||
| CAP 260 | INFORM AFRICA | Role of Data Streams in Informing Infection Dynamics in Africa | Prof Vivek Naranbhai | |
| CAP 262 | ADAP-TIV | Adaptive evaluation of mHealth and conventional adherence support interventions to optimize outcomes with new treatment regimens for drug-resistant tuberculosis and HIV in South Africa | Prof Kogie Naidoo / Dr Max O'Donnell | Cohort Study |
| MATRIX | Microbicide R&D to Advance HIV Prevention Technologies through Responsive Innovation and eXcellence | Dr Leila Mansoor | ||
| PURPOSE 1 | Qualitative Assessment of Oral and Injectable Pre-exposure Prophylaxis Acceptability and Preferences Among Adolescent Girls and Young Women Participating in Study GS-US-412-5624 (PURPOSE 1) PURPOSE 1 Qualitative Component | Dr Disebo Potloane | RCT | |
| STRIVE | A Multicenter, Adaptive, Randomized, Controlled Trial Platform To Evaluate Safety and Efficacy of Strategies and Treatments for Hospitalized Patients with Respiratory Infections” Short title: Strategies and Treatments for Respiratory Infections & Viral Emergencies | Dr Halima Dawood | Cohort Study | |
| Combination Biomarkers | Combination biomarkers for preventing HIV and adverse birth outcomes in a South African pregnancy cohort: implications for infant health | Dr Sinaye Ngcapu | Cohort Study | |
| FRESH BABY U | Vaginal microbiome recovery after childbirth in South African women | Dr Sinaye Ngcapu | Cohort Study | |
| Advanced Genotypic and Phenotypic Monitoring | Advanced Genotypic and Phenotypic Monitoring of Drug-Resistant Mycobacterium tuberculosis to Improve TB Treatment Outcomes | Dr Nesri Padayatchi / Dr Michelle Larsen | ||
| ENGAGE | Acceptability Study of Oral F/TAF vs F/TDF for the Prevention on HIV Acquisision in Adolescent Girls and Young Women (AGYW) | Dr Disebo Potloane | RCT | |
| Formation of the HIV-1 latent resevoir | Formation of the HIV-1 latent resevoir | Dr Nigel Garrett / Dr Ron Swanstrom | Cohort Study | |
| FRESH HPV | Identification of CD8+ T cell correlates of HPV clearance in South African women to inform development of a globally effective therapeutic HPV vaccine | Dr Lenine Liebenberg / Dr Doug Kwon | Cohort Study | |
| Identifying Mechanisms of Microbial-Mediated Host Genital Inflammation | To Identify Mechanisms of Microbial-Mediated Host Genital Inflammation | Dr Lenine Liebenberg / Dr Sinaye Ngcapu / Dr Doug Kwon | Cohort Study | |
| Recovery and study of Lactobacilli from BV patient cohort | Recovery and study of Lactobacilli from BV patient cohort | Dr Sinaye Ngcapu | Cohort Study | |
|
COVPN 3008 |
CoVPN | Multi-Center, Randomized, Efficacy Study of COVID-19 mRNA Vaccine in Regions with SARS-CoV-2 Variants of Concern | Dr Nigel Garrett / Dr Disebo Makhaza | eThekwini / Vulindlela |
| Sisonke (Together) | SAMRC | Open-label, single arm phase 3B implementation study to monitor the effectiveness of the single-dose AD26.COV2. S COVID-19 vaccine among health care workers in South Africa (VAC3158COV3012) | Dr Nigel Garrett / Dr Disebo Makhaza / Dr Nivashnee Naicker | eThekwini / Vulindlela |
| ACTIV-2 A5401 | NIAID | Adaptive Platform Treatment Trial for Outpatients with COVID-19 (Adapt Out COVID) | Prof Kogie Naidoo | Springfield |
| Sisonke 4 (SHERPA) | SAMRC | Sisonke 4 (SHERPA)/ mRNA-1273-P508. Open-label, phase 3 study to evaluate the effectiveness of heterologous mRNA-1273 boosting of the single or two dose Ad26.COV2.S COVID-19 vaccine among health care workers in South Africa | Dr Nigel Garrett / Dr Disebo Makhaza / Dr Nivashnee Naicker | eThekwini / Vulindlela |
| COVPN 305 | CoVPN | A Phase 1 Open-label clinical trial to evaluate the safety and immunogenicity of synthetic DNAs Encoding NP-GT8 and IL-12, with or without a TLR-agonist-adjuvanted HIV Env Trimer 4571 Boost, in Adults without HIV | Dr Nivashnee Naicker | eThekwini |
| COVPN 139 | CoVPN | Protocol funding | Dr Nigel Garrett | eThekwini |
| BASIS Study | SAMRC | Phase II randomised open label trial of full and half dose J&J Ad266.COV2.S and Pfizer BNT162b2 booster vaccinations after receiving the J&J Ad26.COV2.S prime vaccine through SISONKE phase IIIB implementation study | Dr Nigel Garrett / Prof Lee Fairlie | eThekwini |
| COMPLETED | ||||
| CAP 001 | START trial | Starting Tuberculosis and Anti-Retroviral Therapy Trial: A Randomized Controlled Trial to Assess the Effect of Integrated Tuberculosis and HIV Care on the Incidence of AIDS-Defining Conditions or Mortality in participants Co-Infected with Tuberculosis and HIV. | Prof Salim Abdool Karim | RCT |
| CAP 003 | SAPIT trial | A Study to compare three existing starting points of ART Initiation in HIV/TB co-infected patients | Prof Salim Abdool Karim | RCT |
| CAP 004 | Tenofovir gel trial | Phase IIb Trial to Assess the Safety and Effectiveness of the Vaginal Microbicide 1% Tenofovir Gel for the Prevention of HIV Infection in Women in South Africa | Prof Salim Abdool Karim/ Prof Quarraisha Abdool Karim |
RCT |
| CAP 005 | TRuTH study | TB Recurrence upon Treatment with HAART | Prof Kogie Naidoo / Prof Salim Abdool Karim |
Cohort Study |
| CAP 007 | RHIVA | Reducing HIV in Adolescents (RHIVA). A proof of concept cluster randomised controlled trial to evaluate the impact of a cash incentivised prevention intervention to reduce HIV infection in high school llearners in rural KwaZulu-Natal, South Africa | Prof Quarraisha Abdool Karim | RCT |
| CAP 008 | Tenofovir gel implementation trial | Open-Label Randomized Controlled Trial to Assess the Implementation Effectiveness and Safety of 1% Tenofovir Gel Provision through Family Planning Services in KwaZulu-Natal, South Africa | Prof Quarraisha Abdool Karim/ Prof Salim Abdool Karim/ Dr Leila Mansoor | Randomised, Non-inferiority Open-label trial |
| CAP 009 | TOAST | Open Label Randomized Controlled Trial to Assess the Impact of prophylactic exposure to tenofovir gel on the efficacy of subsequent tenofovir-containing antiretroviral therapy on viral suppression | Dr Nivashnee Naicker /Prof Salim Abdool Karim /Dr Anushka Naidoo | RCT |
| CAP 011 | IMPRESS | Improving retreatment success | Dr Nesri Padayatchi | RCT |
| CAP 012A | Broadly Neutralising Antibody | A Phase ǀ Study to determine the Safety and Pharmacokinetics of the Human monoclonal Antibodies, VRC07-523LS and PGT121 administered subcutaneously to HIV negative Adults in South Africa | Prof Salim Abdool Karim | RCT |
| CAP 013 | SUTHI | Addressing challenges in scaling up TB and HIV Treatment integration in Public Health settings in South Africa | Prof Kogie Naidoo | RCT |
| CAP 018 | TAF Implant | A phase I/II trial to assess the safety, acceptability and pharmacokinetics of a sustained-release tenofovir alafenamide sub-dermal implant for HIV prevention in women | Prof Salim Abdool Karim | RCT |
| CAP 050 | Seroincidence study | HIV Incidence Rates in Vulindlela and Durban: A Prevention Preparedness Study (Vulindlela) | Prof Quarraisha Abdool Karim | Cohort Study |
| CAP 051 | Seroincidence study | HIV Incidence Rates in Vulindlela and Durban: A Prevention Preparedness Study(eThekwini) | Prof Quarraisha Abdool Karim | Cohort Study |
| CAP 054 | WiseBag study | A pilot study to assess feasibility of utilizing a prototype Wisebag for enhancing measurement of gel use in CAPRISA 004 | Dr Leila Mansoor / Dr Tanuja Gengiah |
Pilot |
| CAP 055 | ANC Survey (annual) | Temporal trends in HIV infection in rural KwaZulu-Natal - implications for research and programmatic priority setting | Prof Ayesha Kharsany | Survey |
| CAP 056 | XDR-TB & HIV / PROX | A prospective study of treatment outcomes in extensively drug resistant tuberculosis (XDR Study) | Dr Nesri Padayatchi / Dr Max O'Donnell |
Cohort Study |
| CAP 057 | Contraception | Women’s understanding and practices regarding method choice for fertility control and/or disease prevention in KwaZulu-Natal | Dr Cheryl Baxter | Cohort Study |
| CAP 075 | URLPAI | Understanding socio-demographic and behavioral factors that result in patients seeking care with advanced stage HIV/AIDS disease in the context of free public sector access to Antiretroviral Therapy | Prof Kogie Naidoo | Cohort Study |
| CAP 078 | HEPS | Evaluation of HIV-specific Immunological and virological responses of HIV-1 multiply-exposed seronegative individuals | Prof Salim Abdool Karim | Cohort Study |
| CAP 081 | BLIX | A Retrospective Chart Review of Patients with M(X)DR-TB and TB services | Dr Nesri Padayatchi | Chart Review |
| CAP 083 | STI study | Changing the STI care model to reduce genital inflammation and HIV risk in South African women | Dr Nigel Garrett / Prof Anne Rompalo | Cohort Study |
| CAP 082 | PrEP Implementation study | Prospective study of HIV risk factors and prevention choices in young woman in KZN, South Africa | Dr Leila Mansoor | Cohort study |
| CAP 084 | PrEP Implementation study | A demonstration project of daily, oral tenofovir disoproxil fumarate + emtricitabine pre-exposure prophylaxis (PrEP) as part of sexual reproductive health services for young women at high risk of acquiring HIV in KwaZulu-Natal: Informing policy and practice for PrEP scale-up |
Prof Quarraisha Abdool Karim | Implementation Programme |
| CAP 085 | CANS | Identifying sources of HIV infection in adolescent girls in rural South Africa | Prof Ayesha Kharsany | Cohort Study |
| CAP 087 | STREAM Study | Point-of-care viral load testing to enable streamlined care and task shifting for chronic HIV care | Dr Nigel Garrett / Dr Paul Drain |
RCT |
| CAP 088 | HPP study | HIV incidence rates, socio-behavioural and biological HIV risk factors, HIV transmission rates and acceptability of prep during pregnancy and/or post-natally in KwaZulu-Natal | Dr Daya Moodley | Cohort Study |
| CAP 104 | Case Control (004) | Microbicide Case Control Study to evaluate behavioural patterns of risk and gel use in a phase 2b trial | Dr Kate McQueen / Dr Francois van Loggenberg |
Nested case-control study |
| CAP 106 | CAP 106 TFV-SHSR study | CAPRISA 106 Tenofovir Gel Social and Health Systems Research Study | Dr Sarah Dlamini / Dr Kate MacQueen / Dr Kristine Torjesen |
Social Science |
| CAP 251 | HIPSS | Point-of-care viral load testing to enable streamlined care and task shifting for chronic HIV care | Prof Ayesha Kharsany | Cohort Study |
| STI Consultation | Consultant to focus on Sexually Transmitted Infections for the Development of The South Africa National Strategic plan for HIV, TB and STI's 2023 - 2028 | Dr Nigel Garrett | ||
| IAPAC | Identifying Healthcare System Barriers and Solutions to Improve Implementation of Community ART Delivery during and beyond the COVID-19 Pandemic in eThekwini | Dr Jienchi Doward | Observational | |
| CAP 086 | PRAXIS | PRospective study of Adherence in M/XDR-TB Implementation Science | Dr Nesri Padayatchi/ Dr Max O'Donnell | Cohort Study |
| 2019nCoV-501 | Novavax Inc | A Phase 2a/b, Randomized, Observer-Blinded, Placebo-Controlled Study to Evaluate the Efficacy, Immunogenicity, and Safety of a SARS-CoV-2 Recombinant Spike Protein Nanoparticle Vaccine (SARS-CoV-2 rS) With Matrix-M1™ Adjuvant in South African Adults Living Without HIV; and Safety and Immunogenicity in Adults Living With HIV | Prof Daya Moodley | Umlazi |
| CoVPN 5001 | CoVPN | A prospective study of acute immune responses to SARS-CoV-2 infection | Dr Nigel Garrett / Dr Disebo Makhaza / Dr Dishiki Kalonji | eThekwini / Vulindlela / Isipingo |
| ENSEMBLE (CoVPN 3003) | CoVPN |
A Randomized, Double-blind, Placebo-controlled Phase 3 Study to Assess the Efficacy and Safety of Ad26.COV2. S for the Prevention of SARS-CoV-2-mediated COVID-19 in Adults Aged 18 Years and Older | Dr Nigel Garrett / Dr Disebo Makhaza / Dr Elizabeth Spooner | eThekwini / Vulindlela / Botha's Hill / Chatsworth |