A Simulated Clinical Trial to Explore Willingness to Participate and Methods for Improving Reporting of Adherence Among a Sex-worker Cohort in Nellore, India
A simulated microbicides clinical study is being conducted in India to develop and test strategies for improving recruitment, adherence, and the reporting of adherence for future microbicides clinical trials.
The Population Council will conduct a simulated clinical trial among sex workers in Nellore, India. The Council will collaborate on the project with Y.R. Gaitonde Centre for AIDS Research and Education (YRG CARE), a leading Indian research institution based in Chennai.
Researchers aim to evaluate how sex workers who choose to participate in a four-month simulated microbicide trial of a placebo gel differ from their peers who were unwilling to participate. They will also assess whether respondent-driven sampling is likely to be successful for recruiting trial participants.
Other goals of the project are to:
- investigate rates of HIV and other sexually transmitted diseases, including HSV-2 and gonorrhea, among female sex workers who enroll in the simulated microbicide trial;
- compare adherence and high-risk behavior among participants in the simulated trial using a variety of innovative research tools tested within an experimental framework;
- explore whether participants' adherence and/or their reports of sexual activity and use of gel and condoms are affected by advance knowledge that responses will be validated by additional tests; and
- use interactive voice response surveys (IVRS) and audio computer-assisted self-interviewing (ACASI) to collect behavioral data.
An evaluation of methods to improve the reporting of adherence in a placebo gel trial in Andhra Pradesh, India (abstract) (HTML)
Abbott,Sharon; Friedland,Barbara A.; Sarna,Avina; Katzen,Lauren L.; Rawiel,Ulrike; Srikrishnan,Aylur K.; Shalini,C.S.; Tun,Waimar; Kelly,Christine A.; Solomon,Suniti; Mensch,Barbara S.
AIDS and Behavior 17(6): 2222-2236
Publication date: 2013
Characteristics of female sex workers in southern India willing and unwilling to participate in a placebo gel trial (abstract) (HTML)
Mensch,Barbara S.; Friedland,Barbara A.; Abbott,Sharon; Katzen,Lauren L.; Tun,Waimar; Kelly,Clifton A.; Sarna,Avina; Srikrishnan,Aylur K.; Solomon,Suniti
AIDS and Behavior 17(2): 585-597
Publication date: 2013
Sexually transmitted infections and reproductive health morbidity in a cohort of female sex workers screened for a microbicide feasibility study in Nellore, India (abstract) (HTML)
Sarna,Avina; Friedland,Barbara A.; Srikrishnan,Aylur K.; Katzen,Lauren L.; Tun,Waimar; Abbott,Sharon; Rawiel,Ulrike; Kelly,Christine A.; Shalini,C.S.; Solomon,Suniti; Mensch,Barbara S.
Global Journal of Health Science 5(3): 139-149
Publication date: 2013
Validation of a dye stain assay for vaginally inserted hydroxyethylcellulose-filled microbicide applicators (abstract) (HTML)
Katzen,Lauren L.; Fernandez-Romero,Jose A.; Sarna,Avina; Murugavel,Kailapuri G.; Gawarecki,Daniel; Zydowsky,Thomas M.; Mensch,Barbara S.
Sexually Transmitted Diseases 38(11): 1050-1055
Publication date: 2011
Project Stats
Location: India (Nellore)
Program(s):
HIV and AIDS
Topic(s):
Microbicides
Sex workers
Duration: 1/2008 - 1/2012
Population Council researchers:
Barbara Friedland
Lauren Katzen
Barbara S. Mensch
Barbara Miller
Ashutosh Mishra
Avina Sarna
Waimar Tun
Chung Wu
Non-Council collaborators:
Aylur Kailasam Ganseh (Y.R. Gaitonde Centre for AIDS Research and Education)
Aylur Kailasam Srikrishnan (Y.R. Gaitonde Centre for AIDS Research and Education)
C. Shalini (Y.R. Gaitonde Centre for AIDS Research and Education)
G. Gailapuri Murugavel (Y.R. Gaitonde Centre for AIDS Research and Education)
Poongulali Selvamuthu (Y.R. Gaitonde Centre for AIDS Research and Education)
Suniti Solomon (Y.R. Gaitonde Centre for AIDS Research and Education)
Donors:
US Agency for International Development
US National Institutes of Health
Get Involved
- Make a contribution to the Population Council
- Honor a loved one with a gift in his or her name
- Sign up to receive e-mail announcements
Connect
