Research Tools & Forms

HPTN Research Toolkit

Submit a Research Idea

The HPTN is open to receiving concept proposals at any time. Consideration will be given based on available resources and research needs. Please review Section 9 of the HPTN MOP to best understand the concept and protocol development process. HPTN leadership will assess the needs and resources of the network for the proposed work and invite submission of a full concept if there is potential for support. 

Submit your Letter of Intent and any questions to concepts@hptn.org.

Letter of Intent Template

 

Submit a Study Concept

Unless responding to a specific call for concepts, please submit a Letter of Intent (above) prior to submitting a concept.

Study Concept Template

 

Ancillary Study Application

Ancillary studies may involve collection of additional data and/or samples from primary study participants, or use of existing data and/or samples for analyses or laboratory assessments that are not directly related to the specific objectives of the primary study as defined in the protocol document.

Please complete the ancillary study application form as it pertains to your proposed ancillary study and email to the respective study contact. The application must be reviewed by the primary study protocol team, including the Protocol Chair(s), Statistical and Data Management Center (SDMC), HPTN Laboratory Center (LC) and HPTN Leadership and Operations Center (LOC) representatives. The Investigator of Record for each study site to be involved in or affected by the ancillary study must also review the application as well. After the primary study protocol team has reviewed the application, the HPTN LOC will request signature approvals from the Protocol Chair(s), SDMC, LC, and LOC representatives, as applicable. After these approvals are obtained, the HPTN LOC will send the application to the HPTN Executive Committee for final review and approval.

Ancillary Study Application Form

 

Manuscript Review

Submit HPTN-related publications for review by the HPTN Manuscript Review Committee.

  1. Review the MCR process and responsibilities
  2. Fill out the submission form
  3. Submit all materials for review

Acceptability and Use of PrEP Products Among Women Tool

This survey tool was developed in collaboration with the Women's HIV Prevention and Sexual Health Scientific Committee to be used across different HIV prevention clinical trials to assess women’s experiences with investigational products.

Acceptability and Use of PrEP Products Among Women Tool

Read the manuscript

 

Depression Measures Recommendations

The Mental Health Subgroup of the Socio-Behavioral and Structural Working Group was formed to aid the larger working group in developing responses to network-wide issues around mental health. The subgroup has developed a document to provide recommendations for network-wide use of depression measures in HPTN studies, including the PHQ and the CES-D, which can be accessed below. The construct of depressive symptoms is important for both PLHIV and those who may acquire HIV and, thus, should be included in HIV prevention trials.

Depression Measures Recommendations

 

PTSD Measures Recommendations

As mentioned above, the Mental Health Subgroup of the Socio-Behavioral and Structural Working Group was formed to aid the larger working group in developing responses to network-wide issues around mental health. The subgroup has developed a document to provide recommendations for network-wide use of PTSD measures in HPTN studies, including the PC-PTSD-5 and the PCL-5, which can be accessed below. As is the case with depressive symptoms, the construct of PTSD is important for both PLHIV and those who may acquire HIV and, thus, should be included in HIV prevention trials.

PTSD Measures Recommendations

 

Substance Use Measure Identification Tool

The Substance Use Scientific Committee at the HPTN has developed a Web-based, interactive Substance Use Measurement Identification (SUMI) tool to assist researchers to identify the proper biomarkers and behavioral survey tools to assess substance use in the setting of HIV. Based on the parameters entered by the user, the tool will list appropriate survey instruments relevant to particular substance use domains that the user plans to measure. This free, Web-based tool is available to researchers around the globe.

Substance Use Measure Identification Tool

Watch the webinar

DAIDS Site Expansion Information Sheet

The Division of AIDS (DAIDS) has developed this tool to assist the Networks in collecting key information from site leaders who are requesting to expand site services beyond the Main CRS. The Network staff should carefully review and determine if there is a clear and justifiable need to expand beyond the complete list of fully-funded sites that are currently available to the Network to support the specific study. Once the Network staff has made a determination, please submit the completed and signed application to the OCSO Network Liaison for review and internal processing. The final decision will be communicated to all stakeholders by the OCSO Program Officer responsible for the Main CRS and/or CTU proposing to expand their CRS or location.

DAIDS Site Expansion Information Sheet

 

Research Acronyms & Terminology

Download List

 

Training Opportunities

  • DAIDS Learning Portal: Gain access to DAIDS training resources and materials on everything from quality management to laboratory guidelines, clinical site monitoring to community advisory boards.
  • FHI 360 Research Ethics Training Curriculum: Human research ethics rest on three basic principles: respect, beneficence and justice. These principles are the foundation of all regulations or guidelines governing research ethics and transcend all geographic, cultural, economic, legal and political boundaries. Although these principles are universal, FHI 360 Research Ethics Training Curriculum provides researchers with training on the development and philosophy of ethics and how ethical principals can be applied in a practical way. Request network training for your site or region by contacting operations@hptn.org.
  • R01 Investigator Resources: Find resources for R01s, NIH's standard independent research grant.

Community Engagement Recommendations in HIV/AIDS Research

Community representatives working with the National Institute of Allergy and Infectious Diseases (NIAID) at the NIH increasingly believe that this type of guidance was essential and in 2009 sought to develop recommendations as a way to address good community practice. These recommendations are intended as a tool to help research staff and community representatives expand and deepen existing partnerships, and forge new ones, with the ultimate goal of facilitating effective community engagement in all aspects of clinical trials research. Available in English or Spanish.

Community Engagement Recommendations

 

Research Literacy: Understanding Clinical Trials & Training

A basic understanding of clinical trial concepts and practices is necessary for meaningful community input into research study design and implementation. The more communities understand about the purpose and limitations of research in their communities, the more they will be able to take ownership of the process. Research literate community members can contribute early and directly to protocol development, informed consent, and other study-specific materials and decisions. User-friendly approaches and methods are essential in order to make the science accessible to community members.

  • ClinicalTrials.gov provides valuable information on what clinical trials are and answers many frequently asked questions about aspects of participating in clinical trials.
  • Be the Generation HIV Prevention Research (HPR) Training Module is a collaboration of the Legacy Project, FHI 360, HPTN, HVTN, and MTN, provides recent prevention research findings in a curriculum designed to increase scientific literacy of the communities most disproportionately impacted by HIV.
  • Basic Scientific Literacy (BSL) Training Module is designed for participants with little knowledge of basic science and research and can be used as a refresher with more knowledgeable participants.is intended to provide information for community members and service and community based organization staff members funded by the Division of AIDS of the US National Institute of Allergy and Infectious Diseases (NIAID), a part of the National Institutes of Health.

Regulatory Resources

NIH provides Certificates of Confidentiality automatically to any NIH-funded recipients conducting research applicable to the NIH Policy for Issuing Certificates of Confidentiality, for which all HPTN research is applicable. Certificates will be issued to recipients for applicable research regardless of the country where the investigator or the protected information resides. However, Certificates may not be effective for data held in countries outside of the US.

For more information on the CoC, refer to: https://grants.nih.gov/policy/humansubjects/coc.htm.

The HANC-facilitated Financial Disclosure Working Group is pleased to announce the “NIAID (DAIDS)-supported and/or Sponsored HIV/AIDS Clinical Trials Networks Financial Disclosure and Conflict of Interest Guidelines”. The guidelines are intended to identify significant financial interests of network-affiliated researchers and avoid conflicts of interest, or the appearance of such conflicts, in activities of the networks. Network Leaders approved the guidelines on the April 2010 Network Leaders call and the document has been adopted as standard operating procedure (SOP) for all networks effective 15 April 2010.

The NIAID CRMS website includes Clinical Site Monitoring (CSM) system, DAIDS Adverse Event Reporting System (DAERS), DAIDS Protocol Registration System (DPRS), SiteHub, Protocol Management, and Master Contact.

In order to access, you must sign in through a LOGIN.gov account.