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:

  1. A table of all of the clinical trial protocols included in the Protocol Library
  2. A downloadable Excel registry list of all the clinical trial protocols included in the Protocol Library
  3. 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
Andrew, Nunn STREAM

Link to Protocol

First Principal Investigator
Nunn, Andrew

Disease/Disease Area
Tuberculosis

Region of Study
Asia

Site Countries
Bangladesh

Link to Protocol
Bangladesh

Source of Protocol
NEJM

Approximate Page Count
222

Date of Scientific Journal Publication
28/03/2019

Scientific Journal Publication
A Trial of a Shorter Regimen for Rifampin-Resistant Tuberculosis

Tuberculosis Asia
Danel, Christine ANRS 12136 Temprano

Link to Protocol

First Principal Investigator
Danel, Christine

Disease/Disease Area
Tuberculosis

Region of Study
Africa

Site Countries
Ivory Coast

Link to Protocol
Ivory Coast

Source of Protocol
NEJM

Approximate Page Count
124

Date of Scientific Journal Publication
27/08/2015

Scientific Journal Publication
A Trial of Early Antiretrovirals and Isoniazid Preventive Therapy in Africa

Tuberculosis Africa
Guy, Marks A Randomized controlled trial of community-based screening for tuberculosis (the ACT 3 studies)

Link to Protocol

First Principal Investigator
Marks, Guy

Disease/Disease Area
Tuberculosis

Region of Study
Asia

Site Countries
Vietnam

Link to Protocol
Vietnam

Source of Protocol
NEJM

Approximate Page Count
113

Date of Scientific Journal Publication
03/10/2019

Scientific Journal Publication
Community-wide Screening for Tuberculosis in a High-Prevalence Setting

Tuberculosis Asia
Graeme, Meintjes Pred-ART trial

Link to Protocol

First Principal Investigator
Meintjes, Graeme

Disease/Disease Area
Tuberculosis

Region of Study
Africa

Site Countries
South Africa

Link to Protocol
South Africa

Source of Protocol
NEJM

Approximate Page Count
160

Date of Scientific Journal Publication
18/11/2018

Scientific Journal Publication
Prednisone for the Prevention of Paradoxical Tuberculosis-Associated IRIS

Tuberculosis Africa
Mitj, Oriol Yaws elimination on Lihir Island, New Ireland Province, PNG: A proof of principle of Mass Drug Treatment with azithromycin

Link to Protocol

First Principal Investigator
Mitj, Oriol

Disease/Disease Area
Yaws

Region of Study
Oceania

Site Countries
Papua New Guinea

Link to Protocol
Papua New Guinea

Source of Protocol
NEJM

Approximate Page Count
66

Date of Scientific Journal Publication
19/02/2015

Scientific Journal Publication
Mass Treatment with Single-Dose Azithromycin for Yaws

Yaws Oceania
Anne, Hansen Electricity-free Infant Warmer for Newborn Thermoregulation

Link to Protocol

First Principal Investigator
Hansen, Anne

Disease/Disease Area
Hypothermia

Region of Study
Africa

Site Countries
Rwanda

Link to Protocol
Rwanda

Source of Protocol
Clinicaltrials.gov

Approximate Page Count
56

Date of Scientific Journal Publication
21/12/2018

Scientific Journal Publication
A low cost, re-usable electricity-free infant warmer: evaluation of safety, effectiveness and feasibiliy

Hypothermia Africa
Daniel, Roth Randomized placebo-controlled trial of maternal vitamin D supplementation during pregnancy and lactation to improve infant linear growth in Dhaka, Bangladesh

Link to Protocol

First Principal Investigator
Roth, Daniel

Disease/Disease Area
Stunting

Region of Study
Asia

Site Countries
Bangladesh

Link to Protocol
Bangladesh

Source of Protocol
NEJM

Approximate Page Count
192

Date of Scientific Journal Publication
09/08/2018

Scientific Journal Publication
Vitamin D Supplementation in Pregnancy and Lactation and Infant Growth

Stunting Asia
Sharon, Greene Impact of Cryotherapy versus Loop Electrosurgical Excision Procedure (LEEP) on Recurrence of Cervical Intraepithelial Neoplasia and HIV-1 Cervical Shedding among HIV-positive Women

Link to Protocol

First Principal Investigator
Greene, Sharon

Disease/Disease Area
Maternal

Region of Study
Africa

Site Countries
Kenya

Link to Protocol
Kenya

Source of Protocol
JAMA

Approximate Page Count
296

Date of Scientific Journal Publication
22/10/2019

Scientific Journal Publication
Effect of Cryotherapy vs Loop Electrosurgical Excision Procedure on Cervical Disease Recurrence Among Women With HIV and High-Grade Cervical Lesions in Kenya A Randomized Clinical Trial

Maternal Africa
Firdausi, Qadri 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<99>) in Dhaka, Bangladesh

Link to Protocol

First Principal Investigator
Qadri, Firdausi

Disease/Disease Area
Cholera

Region of Study
Asia

Site Countries
Bangladesh

Link to Protocol
Bangladesh

Source of Protocol
NEJM

Approximate Page Count
124

Date of Scientific Journal Publication
06/05/2016

Scientific Journal Publication
Efficacy of a Single-Dose, Inactivated Oral Cholera Vaccine in Bangladesh

Cholera Asia
Sheila, Isanaka 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 Niger

Link to Protocol

First Principal Investigator
Isanaka, Sheila

Disease/Disease Area
Rotavirus

Region of Study
Africa

Site Countries
Niger

Link to Protocol
Niger

Source of Protocol
NEJM

Approximate Page Count
210

Date of Scientific Journal Publication
23/03/2017

Scientific Journal Publication
Efficacy of a Low-Cost, Heat-Stable Oral Rotavirus Vaccine in Niger

Rotavirus Africa
Mila, Shakya Assessing the impact of a Vi-Polysaccharide Conjugate Vaccine in preventing typhoid infections among Nepalese children <96> a Phase III trial

Link to Protocol

First Principal Investigator
Shakya, Mila

Disease/Disease Area
Typhoid

Region of Study
Asia

Site Countries
Nepal

Link to Protocol
Nepal

Source of Protocol
NEJM

Approximate Page Count
104

Date of Scientific Journal Publication
05/12/2019

Scientific Journal Publication
Phase 3 Efficacy Analysis of a Typhoid Conjugate Vaccine Trial in Nepal

Typhoid Asia
Kate, Winskell A Mobile Phone Game to Prevent HIV among Young Africans

Link to Protocol

First Principal Investigator
Winskell, Kate

Disease/Disease Area
HIV

Region of Study
Africa

Site Countries
Kenya

Link to Protocol
Kenya

Source of Protocol
clinicaltrials.gov

Approximate Page Count
127

Date of Scientific Journal Publication
01/08/2018

Scientific Journal Publication
A Mobile Phone Game to Prevent HIV Among Young Africans

HIV Africa
Helen, Ayles A Study of the HIV Prevention Trials Network

Link to Protocol

First Principal Investigator
Ayles, Helen

Disease/Disease Area
HIV

Region of Study
Africa

Site Countries
Zambia, South Africa

Link to Protocol
Zambia, South Africa

Source of Protocol
clinicaltrials.gov

Approximate Page Count
166

Date of Scientific Journal Publication
15/07/2016

Scientific Journal Publication
“The difference that makes a difference”: highlighting the role of variable contexts within an HIV Prevention Community Randomised Trial (HPTN 071/PopART) in 21 study communities in Zambia and South Africa

HIV Africa
Diane, Havlir Sustainable East Africa Research in Community Health (SEARCH)

Link to Protocol

First Principal Investigator
Havlir, Diane

Disease/Disease Area
HIV

Region of Study
Africa

Site Countries
Uganda, Kenya

Link to Protocol
Uganda, Kenya

Source of Protocol
NEJM

Approximate Page Count
240

Date of Scientific Journal Publication
18/07/2019

Scientific Journal Publication
HIV Testing and Treatment with the Use of a Community Health Approach in Rural Africa

HIV Africa
William, Venter 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 Therapy

Link to Protocol

First Principal Investigator
Venter, William

Disease/Disease Area
HIV

Region of Study
Africa

Site Countries
South Africa

Link to Protocol
South Africa

Source of Protocol
NEJM

Approximate Page Count
183

Date of Scientific Journal Publication
29/08/2019

Scientific Journal Publication
Dolutegravir plus Two Different Prodrugs of Tenofovir to Treat HIV

HIV Africa
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 WOMEN

Link to Protocol

First Principal Investigator
Nel, Annalene

Disease/Disease Area
HIV

Region of Study
Africa

Site Countries
South Africa

Link to Protocol
South Africa

Source of Protocol
NEJM

Approximate Page Count
357

Date of Scientific Journal Publication
01/12/2016

Scientific Journal Publication
Safety and Efficacy of a Dapivirine Vaginal Ring for HIV Prevention in Women

HIV Africa
Thuy, Le Itraconazole versus Amphotericin B for the Treatment of Penicilliosis

Link to Protocol

First Principal Investigator
Le, Thuy

Disease/Disease Area
HIV

Region of Study
Asia

Site Countries
Vietnam

Link to Protocol
Vietnam

Source of Protocol
NEJM

Approximate Page Count
148

Date of Scientific Journal Publication
15/06/2017

Scientific Journal Publication
A Trial of Itraconazole or Amphotericin B for HIV-Associated Talaromycosis

HIV Asia
Sle, Molloy 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 meningitis

Link to Protocol

First Principal Investigator
Molloy, Sle

Disease/Disease Area
Meningitis

Region of Study
Africa

Site Countries
Malawi, Tanzania, Zambia, Cameroon

Link to Protocol
Malawi, Tanzania, Zambia, Cameroon

Source of Protocol
NEJM

Approximate Page Count
181

Date of Scientific Journal Publication
15/03/2018

Scientific Journal Publication
Antifungal Combinations for Treatment of Cryptococcal Meningitis in Africa

Meningitis Africa
Merlin, Robb HIV-1 Prevalence, Incidence, Cohort Retention, and Host Genetics and Viral Diversity in Cohorts in East Africa and Thailand

Link to Protocol

First Principal Investigator
Robb, Merlin

Disease/Disease Area
HIV

Region of Study
Asia

Site Countries
Thailand

Link to Protocol
Thailand

Source of Protocol
NEJM

Approximate Page Count
450

Date of Scientific Journal Publication
02/06/2016

Scientific Journal Publication
Prospective Study of Acute HIV-1 Infection in Adults in East Africa and Thailand

HIV Asia
Niklaus, Labhardt 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 trial

Link to Protocol

First Principal Investigator
Labhardt, Niklaus

Disease/Disease Area
HIV

Region of Study
Africa

Site Countries
Lesotho

Link to Protocol
Lesotho

Source of Protocol
JAMA

Approximate Page Count
89

Date of Scientific Journal Publication
20/03/2018

Scientific Journal Publication
Effect of Offering Same-Day ART vs Usual Health Facility Referral During Home-Based HIV Testing on Linkage to Care and Viral Suppression Among Adults With HIV in Lesotho The CASCADE Randomized Clinical Trial

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).

Human Immunodeficiency Virus

Neglected Tropical Diseases

Tuberculosis

Malaria

Maternal, Newborn, & Child Health

Nutrition

Vaccines

Enteric & Diarrheal Diseases

Pneumonia

Polio

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.