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 |
| Keenan, Jeremy |
Mortality Reduction After Oral AzithromycinLink to ProtocolFirst Principal InvestigatorKeenan, Jeremy Disease/Disease AreaPneumonia Site CountriesMalawi, Niger, Tanzania Source of ProtocolNEJM Approximate Page Count183 Date of Scientific Journal Publication4/26/2018 Scientific Journal Publicationhttps://www.nejm.org/doi/full/10.1056/NEJMoa1715474 |
Pneumonia | Africa |
| Heyderman, Robert |
Group B streptococcus vaccination in pregnant women with or without HIV in Africa: a non-randomised phase 2, open-label, multicentre trialLink to ProtocolFirst Principal InvestigatorHeyderman, Robert Disease/Disease AreaGroup B Strep Sub AreaHIV Site CountriesSouth Africa, Malawi Source of ProtocolLancet Approximate Page Count47 Date of Scientific Journal Publication2/8/2016 Scientific Journal Publicationhttps://www.thelancet.com/journals/laninf/article/PIIS1473-3099(15)00484-3/fulltext |
Group B Strep | Africa |
| Le, Thuy |
Itraconazole versus Amphotericin B for the Treatment of PenicilliosisLink to ProtocolFirst Principal InvestigatorLe, Thuy Disease/Disease AreaHIV Sub AreaPenicilliosis Site CountriesVietnam Source of ProtocolNEJM Approximate Page Count148 Date of Scientific Journal Publication6/15/2017 Scientific Journal Publicationhttps://www.nejm.org/doi/full/10.1056/NEJMoa1613306 |
HIV | Asia |
| Fowler, Mary |
IMPAACT 1077BFLink to ProtocolFirst Principal InvestigatorFowler, Mary Disease/Disease AreaHIV Site CountriesIndia, Malawi, South Africa, Tanzania, Uganda, Zambia, Zimbabwe Source of ProtocolNEJM Approximate Page Count900 Date of Scientific Journal Publication11/3/2016 Scientific Journal Publicationhttps://www.nejm.org/doi/full/10.1056/NEJMoa1511691#article_supplementary_material |
HIV | Multi |
| Luby, Stephen |
A randomized controlled trial of the benefits of water sanitation hygiene plus nutrition interventions on child growth.Link to ProtocolFirst Principal InvestigatorLuby, Stephen Disease/Disease AreaStunting Site CountriesBangladesh Source of ProtocolPI Email Approximate Page Count317 Date of Scientific Journal Publication3/1/2018 Scientific Journal Publicationhttps://www.thelancet.com/journals/langlo/article/PIIS2214-109X(17)30490-4/fulltext |
Stunting | Asia |
| Clarke, Ed |
A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety,
Tolerability, Lot-to-Lot Consistency, Immunogenicity, and Non-
Interference with Concomitant Vaccinations of Serum Institute of
India’s 10-Valent Pneumococcal Conjugate Vaccine
(PNEUMOSIL®) in Healthy Infants in The GambiaLink to ProtocolFirst Principal InvestigatorClarke, Ed Disease/Disease AreaPneumonia Site CountriesGambia Source of ProtocolPI Email Approximate Page Count89 Date of Scientific Journal Publication12/14/2019 Scientific Journal Publicationhttps://www.sciencedirect.com/science/article/pii/S0264410X1931148X?via%3Dihub |
Pneumonia | Africa |
| Llanos-Cuentas, Alejandro |
Tafenoquine vs. Primaquine to prevent relapse in Plasmodium vivax MalariaLink to ProtocolFirst Principal InvestigatorLlanos-Cuentas, Alejandro Disease/Disease AreaMalaria Site CountriesPeru, Brazil, Vietnam, Thailand, Colombia Source of ProtocolNEJM Approximate Page Count401 Date of Scientific Journal Publication1/17/2019 Scientific Journal Publicationhttps://www.nejm.org/doi/full/10.1056/NEJMoa1802537 |
Malaria | Multi |
| Nel, Annalene |
A MULTI-CENTRE, RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED
PHASE II LONG-TERM SAFETY TRIAL OF A DAPIVIRINE VAGINAL MATRIX RING IN
HEALTHY HIV-NEGATIVE WOMENLink to ProtocolFirst Principal InvestigatorNel, Annalene Disease/Disease AreaHIV Sub AreaMAT Site CountriesSouth Africa Source of ProtocolNEJM Approximate Page Count357 Date of Scientific Journal Publication12/1/2016 Scientific Journal Publicationhttps://www.nejm.org/doi/full/10.1056/NEJMoa1602046 |
HIV | Africa |
| Molloy, Síle |
A randomised controlled trial of oral fluconazole plus flucytosine versus amphotericin B-based therapy, for one or two weeks, for initial treatment of HIV-associated cryptococcal meningitisLink to ProtocolFirst Principal InvestigatorMolloy, Síle Disease/Disease AreaMeningitis Site CountriesMalawi, Tanzania, Zambia, Cameroon Source of ProtocolNEJM Approximate Page Count181 Date of Scientific Journal Publication3/15/2018 Scientific Journal Publicationhttps://www.nejm.org/doi/full/10.1056/NEJMoa1710922 |
Meningitis | Africa |
| Groome, Michelle |
A Phase I/II double-blind, randomized, placebo-controlled, descending-age, dose-escalation study to examine the safety, tolerability and immunogenicity of the trivalent P2-VP8 subunit rotavirus vaccine in healthy South African adults, toddlers and infants First Principal InvestigatorGroome, Michelle Disease/Disease AreaRotavirus Sub AreaVAC Site CountriesSouth Africa Source of ProtocolPI Email Approximate Page Count120 Date of Scientific Journal Publication5/5/2017 Scientific Journal Publicationhttps://www.thelancet.com/journals/laninf/article/PIIS1473-3099(20)30001-3/fulltext |
Rotavirus | Africa |
| Alexander, Elizabeth |
A Phase 3, Randomized, Double-Blind, Double-Dummy Study to Compare the Efficacy and Safety of Oral Lefamulin (BC-3781) Versus Oral Moxifloxacin in Adults With Community-Acquired Bacterial PneumoniaLink to ProtocolFirst Principal InvestigatorAlexander, Elizabeth Disease/Disease AreaPneumonia Site CountriesArgentina, Brazil, Chile, Mexico, Peru, US, Bulgaria, Georgia, Latvia, Russia, Serbia, Ukraine, Hungary, Poland, Spain, Philippines, South Korea, Taiwan, South Africa Source of ProtocolJAMA Approximate Page Count175 Date of Scientific Journal Publication9/27/2019 Scientific Journal Publicationhttps://jamanetwork.com/journals/jama/fullarticle/2752331?resultClick=1 |
Pneumonia | Multi |
| Ara, Gulshan |
Impact of nutrition intervention (counselling, food voucher for recipe, WASH and home fortification) on growth and feeding practices of under two years children in SHIMA working areaLink to ProtocolFirst Principal InvestigatorAra, Gulshan Disease/Disease Area Site CountriesBangladesh Source of ProtocolPI Email Approximate Page Count130 Date of Scientific Journal Publication11/1/2019 Scientific Journal Publicationhttps://bmcpublichealth.biomedcentral.com/articles/10.1186/s12889-019-7777-y |
Asia | |
| Robb, Merlin |
HIV-1 Prevalence, Incidence, Cohort Retention, and Host Genetics and
Viral Diversity in Cohorts in
East Africa and ThailandLink to ProtocolFirst Principal InvestigatorRobb, Merlin Disease/Disease Area Site CountriesThailand Source of ProtocolNEJM Approximate Page Count450 Date of Scientific Journal Publication6/2/2016 Scientific Journal Publicationhttps://www.nejm.org/doi/full/10.1056/NEJMoa1508952 |
Asia | |
| Kharsany, Ayesha |
HIV Incidence Provincial Surveillance System (HIPSS) A longitudinal study to monitor HIV incidence trends in the uMgungundlovu District, KwaZulu-Natal, South AfricaLink to ProtocolFirst Principal InvestigatorKharsany, Ayesha Disease/Disease AreaHIV Site CountriesSouth Africa Source of ProtocolPI Email Approximate Page Count189 Date of Scientific Journal Publication11/1/2019 Scientific Journal Publicationhttps://jamanetwork.com/journals/jamanetworkopen/fullarticle/2753789 |
HIV | Africa |
| Goldenberg, Robert |
First Look: A Cluster-Randomized Trial of Ultrasound use to improve pregnancy outcomes in low income country settingsLink to ProtocolFirst Principal InvestigatorGoldenberg, Robert Disease/Disease Area Site CountriesIndia, Pakistan, Kenya, Zambia, Guatemala Source of ProtocolPI Email Approximate Page Count58 Date of Scientific Journal Publication6/15/2018 Scientific Journal Publicationhttps://pubmed.ncbi.nlm.nih.gov/29782696/ |
Multi | |
| Qadri, Firdausi |
A Randomized, Double-blind, Placebo-controlled Study evaluating the safety, tolerability, and immunogenicity of an oral inactivated ETEC Vaccine (ETVAX) alone and together with dmLT adjuvant in descending age groups in Bangladesh First Principal InvestigatorQadri, Firdausi Disease/Disease AreaE. coli Site CountriesBangladesh Source of ProtocolClinicaltrials.gov Approximate Page Count65 Date of Scientific Journal Publication11/19/2019 Scientific Journal Publicationhttps://www.thelancet.com/journals/laninf/article/PIIS1473-3099(19)30571-7/fulltext |
E. coli | Asia |
| Greene, Sharon |
Impact of Cryotherapy versus Loop Electrosurgical Excision Procedure (LEEP) on Recurrence of Cervical Intraepithelial Neoplasia and HIV-1 Cervical Shedding among HIV-positive WomenLink to ProtocolFirst Principal InvestigatorGreene, Sharon Disease/Disease Area Site CountriesKenya Source of ProtocolJAMA Approximate Page Count296 Date of Scientific Journal Publication10/22/2019 Scientific Journal Publicationhttps://jamanetwork.com/journals/jama/fullarticle/2753370?resultClick=1 |
Africa | |
| Etheredge, Analee |
Prenatal Iron Supplements: Safety & Efficacy in TanzaniaLink to ProtocolFirst Principal InvestigatorEtheredge, Analee Disease/Disease AreaAnemia Sub AreaNUT Site CountriesTanzania Source of ProtocolJAMA Approximate Page Count46 Date of Scientific Journal Publication10/1/2015 Scientific Journal Publicationhttps://jamanetwork.com/journals/jamapediatrics/fullarticle/2427520?resultClick=1 |
Anemia | Africa |
| Labhardt, Niklaus |
Same-day antiretroviral therapy versus clinic referral and pre-ART counselling during home-based HIV testing in rural Lesotho (CASCADE trial): An open-label randomized controlled trialLink to ProtocolFirst Principal InvestigatorLabhardt, Niklaus Disease/Disease Area Site CountriesLesotho Source of ProtocolJAMA Approximate Page Count89 Date of Scientific Journal Publication3/20/2018 Scientific Journal Publicationhttps://jamanetwork.com/journals/jama/fullarticle/2674479?resultClick=1 |
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 |
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.
