Table 1.

Typology of collaborative behavioral and social sciences research (BSSR) and clinical research in biomedical HIV prevention clinical trials

Approach	Timeline	Objectives	Integration in protocol and consent form(s)	Study population	Funding	Trial examples
Formative	Before clinical trial initiation	1. Determine whether the proposed clinical trial is acceptable to the community and meets their needs 2. Inform clinical and non-clinical-related components of the trial 3. Identify strategies for addressing challenges that arose in prior clinical trials	Separate BSSR protocol and consent form(s)	Prospective trial participants Other key stakeholders	Often same funder as the clinical trial	Breastfeeding, Antiretroviral, and Nutrition (BAN) study Community preparedness for vaccine trials FEM-PrEP (FEM-PrEP Site Preparedness Protocol)
Embedded	During clinical trial implementation	1. Provide context for the clinical trial findings 2. Answer separate but related BSSR questions 3. Inform clinical trial procedures in “real time”	Information about the BSSR and clinical study procedures is integrated into a single protocol and consent form(s)	Trial participants	Often same funder as the clinical trial	FEM-PrEP HIVIS03 HPTN 084 IPERGAY MDP 301 MTN 020 MTN 023/ IPM 030 MTN 034/ IPM 045
Parallel	During clinical trial implementation	1. Provide context for the clinical trial findings 2. Answer separate but related BSSR questions 3. Inform future clinical research and rollout	Separate BSSR protocol and consent form(s)	Trial participants Other key stakeholders	Same or different funder from the clinical trial	CAPRISA 004 (The Nested Case–Control Study) Carraguard ÉCLAIR HPTN 035 (HPTN 035A) iPrEx Kenya RCT of male circumcision Partners PrEP VAX 004 VOICE (VOICE C)
Explanatory	After clinical trial implementation	Explain or provide context for clinical trial findings	Separate BSSR protocol and consent form(s), or amendment to an existing protocol	Trial participants Other key stakeholders	Often same funder as the clinical trial	CONRAD Cellulose Sulfate FACTS 001 FEM-PrEP (FEM-PrEP Follow-Up Protocol) Mira VOICE (VOICE D)
Implications	After clinical trial implementation	Explore the behavioral and social implications of the clinical trial findings and/or participation	Separate BSSR protocol and consent form(s)	Trial participants Other key stakeholders	Same or different funder from the clinical trial	HIVIS03

Refer to the manuscript and supplemental tables for details and references