Clinical Trial Protocol Registry and Library
Design, Analyze, Communicate: Working together to improve clinical study outcomes.
Focusing on research Protocols where the trial sites were located in low- and middle-income countries, this resource includes three ways to access the Protocol Library:
- A table of all of the clinical trial protocols included in the Protocol Library
- A downloadable Excel registry list of all the clinical trial protocols included in the Protocol Library
- The Protocol Library sorted into disease area folders to allow direct access to relevant protocols
Clinical Trial Protocol Registry Table
Use this table to filter the Protocol Library to access specific protocols.
Filter the resources using the dropdown menus. Select a column heading to sort. Click or tap on a row to view the full record
| First Principal Investigator | Protocol Title | Disease/Disease Area | Region of Study |
| Maitland, Kathryn |
TRACTLink to ProtocolFirst Principal InvestigatorMaitland, Kathryn Disease/Disease AreaAnemia Site CountriesMalawi, Uganda Source of ProtocolNEJM Approximate Page Count194 Date of Scientific Journal Publication8/1/2019 Scientific Journal Publicationhttps://www.nejm.org/doi/full/10.1056/NEJMoa1900100#article_supplementary_material |
Anemia | Africa |
| Humphrey, Jean |
Sanitation Hygiene Infant Nutrition Efficacy ProjectLink to ProtocolFirst Principal InvestigatorHumphrey, Jean Disease/Disease AreaStunting Site CountriesZimbabwe Source of ProtocolLancet Approximate Page Count91 Date of Scientific Journal Publication1/1/2019 Scientific Journal Publicationhttps://pubmed.ncbi.nlm.nih.gov/30554749/ |
Stunting | Africa |
| Ruel, Marie |
Strengthening and Evaluating the “Preventing Malnutrition in Children Under Two Years of Age Approach” (PM2A) in Guatemala and BurundiLink to ProtocolFirst Principal InvestigatorRuel, Marie Disease/Disease AreaStunting Site CountriesBurundi Source of ProtocolPI Email Approximate Page Count111 Date of Scientific Journal Publication3/1/2018 Scientific Journal Publicationhttps://pubmed.ncbi.nlm.nih.gov/29546306/ |
Stunting | Africa |
| Marks, Guy |
A Randomized controlled trial of community-based
screening for tuberculosis (the ACT 3 studies)Link to ProtocolFirst Principal InvestigatorMarks, Guy Disease/Disease AreaTuberculosis Site CountriesVietnam Source of ProtocolNEJM Approximate Page Count113 Date of Scientific Journal Publication10/3/2019 Scientific Journal Publicationhttps://www.nejm.org/doi/full/10.1056/NEJMoa1902129 |
Tuberculosis | Asia |
| Danel, Christine |
ANRS 12136 TempranoLink to ProtocolFirst Principal InvestigatorDanel, Christine Disease/Disease AreaTuberculosis Sub AreaHIV Site CountriesIvory Coast Source of ProtocolNEJM Approximate Page Count124 Date of Scientific Journal Publication8/27/2015 Scientific Journal Publicationhttps://www.nejm.org/doi/full/10.1056/NEJMoa1507198 |
Tuberculosis | Africa |
| Nunn, Andrew |
STREAMLink to ProtocolFirst Principal InvestigatorNunn, Andrew Disease/Disease AreaTuberculosis Site CountriesBangladesh Source of ProtocolNEJM Approximate Page Count222 Date of Scientific Journal Publication3/28/2019 Scientific Journal Publicationhttps://www.nejm.org/doi/full/10.1056/NEJMoa1811867 |
Tuberculosis | Asia |
| Suliman, Sara |
A Phase I/IIa Double-Blind, Randomized, Placebo-Controlled, Dose-Finding Study to Evaluate the Safety and Immunogenicity of AERAS-456 in HIV-negative Adults with and without Latent Tuberculosis InfectionLink to ProtocolFirst Principal InvestigatorSuliman, Sara Disease/Disease AreaTuberculosis Site CountriesSouth Africa Source of Protocolclinicaltrials.gov Approximate Page Count74 Date of Scientific Journal Publication1/15/2019 Scientific Journal Publicationhttps://www.atsjournals.org/doi/10.1164/rccm.201802-0366OC?url_ver=Z39.88-2003&rfr_id=ori%3Arid%3Acrossref.org&rfr_dat=cr_pub++0pubmed& |
Tuberculosis | Africa |
| Winskell, Kate |
A Mobile Phone Game to Prevent HIV among Young Africans First Principal InvestigatorWinskell, Kate Disease/Disease AreaHIV Site CountriesKenya Source of Protocolclinicaltrials.gov Approximate Page Count127 Date of Scientific Journal Publication8/1/2018 Scientific Journal Publicationhttps://pubmed.ncbi.nlm.nih.gov/30068501/ |
HIV | Africa |
| Mitjà, Oriol |
Yaws elimination on Lihir Island, New Ireland Province, PNG: A
proof of principle of Mass Drug Treatment with azithromycinLink to ProtocolFirst Principal InvestigatorMitjà, Oriol Disease/Disease AreaYaws Site CountriesPapua New Guinea Source of ProtocolNEJM Approximate Page Count66 Date of Scientific Journal Publication2/19/2015 Scientific Journal Publicationhttps://www.nejm.org/doi/full/10.1056/NEJMoa1408586 |
Yaws | Oceania |
| Tinto, Halidou |
Extension to study MALARIA-055 PRI (110021) for
evaluation of long-term efficacy, safety and
immunogenicity of GSK Biologicals’candidate
malaria vaccine (SB257049) in infants and children
in AfricaLink to ProtocolFirst Principal InvestigatorTinto, Halidou Disease/Disease AreaMalaria Site CountriesTanzania, Kenya, Burkina Faso Source of Protocolclinicaltrials.gov Approximate Page Count98 Date of Scientific Journal Publication8/19/2019 Scientific Journal Publicationhttps://pubmed.ncbi.nlm.nih.gov/31300331/ |
Malaria | Africa |
| Shakya, Mila |
Assessing the impact of a Vi-Polysaccharide Conjugate Vaccine in
preventing typhoid infections among Nepalese children – a Phase III trialLink to ProtocolFirst Principal InvestigatorShakya, Mila Disease/Disease AreaTyphoid Site CountriesNepal Source of ProtocolNEJM Approximate Page Count104 Date of Scientific Journal Publication12/5/2019 Scientific Journal Publicationhttps://www.nejm.org/doi/full/10.1056/NEJMoa1905047 |
Typhoid | Asia |
| Qadri, Firdausi |
An individually randomized, placebo-controlled trial to measure the protection
conferred by a single dose regimen of bivalent, killed, whole cell oral cholera vaccine (Shanchol™)
in Dhaka, BangladeshLink to ProtocolFirst Principal InvestigatorQadri, Firdausi Disease/Disease AreaCholera Site CountriesBangladesh Source of ProtocolNEJM Approximate Page Count124 Date of Scientific Journal Publication5/6/2016 Scientific Journal Publicationhttps://www.nejm.org/doi/full/10.1056/NEJMoa1510330 |
Cholera | Asia |
| Isanaka, Sheila |
Randomized, double-blind, placebo-controlled phase III clinical trial to assess the efficacy and safety of a
pentavalent rotavirus vaccine (BRV-PV) against severe rotavirus gastroenteritis among infants in NigerLink to ProtocolFirst Principal InvestigatorIsanaka, Sheila Disease/Disease AreaRotavirus Site CountriesNiger Source of ProtocolNEJM Approximate Page Count210 Date of Scientific Journal Publication3/23/2017 Scientific Journal Publicationhttps://www.nejm.org/doi/full/10.1056/NEJMoa1609462 |
Rotavirus | Africa |
| Venter, William |
A 96-week Randomised, Phase 3 Non-inferiority Study of DTG + TAF + FTC Compared with DTG + TDF + FTC and EFV + TDF + FTC in Patients Infected with HIV-1
Starting First-line Antiretroviral TherapyLink to ProtocolFirst Principal InvestigatorVenter, William Disease/Disease AreaHIV Site CountriesSouth Africa Source of ProtocolNEJM Approximate Page Count183 Date of Scientific Journal Publication8/29/2019 Scientific Journal Publicationhttps://www.nejm.org/doi/full/10.1056/NEJMoa1902824 |
HIV | Africa |
| Meintjes, Graeme |
Pred-ART trialLink to ProtocolFirst Principal InvestigatorMeintjes, Graeme Disease/Disease AreaTuberculosis Site CountriesSouth Africa Source of ProtocolNEJM Approximate Page Count160 Date of Scientific Journal Publication11/18/2018 Scientific Journal Publicationhttps://www.nejm.org/doi/full/10.1056/NEJMoa1800762 |
Tuberculosis | Africa |
| Havlir, Diane |
Sustainable East Africa Research in Community Health (SEARCH)Link to ProtocolFirst Principal InvestigatorHavlir, Diane Disease/Disease AreaHIV Site CountriesUganda, Kenya Source of ProtocolNEJM Approximate Page Count240 Date of Scientific Journal Publication7/18/2019 Scientific Journal Publicationhttps://www.nejm.org/doi/full/10.1056/NEJMoa1809866#article_supplementary_material |
HIV | Africa |
| Ayles, Helen |
A Study of the HIV Prevention Trials NetworkLink to ProtocolFirst Principal InvestigatorAyles, Helen Disease/Disease AreaHIV Site CountriesZambia, South Africa Source of Protocolclinicaltrials.gov Approximate Page Count166 Date of Scientific Journal Publication7/15/2016 Scientific Journal Publicationhttps://pubmed.ncbi.nlm.nih.gov/27421057/ |
HIV | Africa |
| Ahmed, Rukhsana |
STOPMIP IndonesiaLink to ProtocolFirst Principal InvestigatorAhmed, Rukhsana Disease/Disease AreaMalaria Site CountriesIndonesia Source of ProtocolThe Lancet, Infectious Diseases Approximate Page Count91 Date of Scientific Journal Publication7/25/2019 Scientific Journal Publicationhttps://www.thelancet.com/journals/laninf/article/PIIS1473-3099(19)30156-2/fulltext |
Malaria | Asia |
| Tait, Dereck |
A phase IIb, double-blind, randomised, placebocontrolled study to evaluate the efficacy, safety, and immunogenicity of GSK Biologicals’ candidate tuberculosis (TB) vaccine GSKLink to ProtocolFirst Principal InvestigatorTait, Dereck Disease/Disease AreaTuberculosis Site CountriesZambia, South Africa, Kenya Source of ProtocolNEJM Approximate Page Count387 Date of Scientific Journal Publication12/19/2019 Scientific Journal Publicationhttps://www.nejm.org/doi/full/10.1056/NEJMoa1909953 |
Tuberculosis | Africa |
Downloadable Clinical Trial Protocol Registry
Download the Clinical Trial Protocol Registry to access a detailed Excel spreadsheet of all the publicly available global health protocols included in the Protocol Library and the links to access them.
Protocol Library
The Protocol Library includes publicly available global health trial protocols (sorted into disease area folders).
Please note: Implementors of studies should also always refer to relevant regulatory standards and guidelines (e.g. FDA, EMA) to assist with study/protocol design.
