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PROJECT
Evaluating Services for Women Who Test
HIV-positive During the Phase 3 Trial

This project (formally titled "Evaluating the Strategies for Care and Support of Women Who Test Positive for HIV During the Phase 3 Study of the Efficacy and Safety of the Microbicide Carraguard®") assessed referrals for care in order to:

  • gauge whether the women accessed the services in the referral networks;

  • document reasons why the women used the services;

  • identify any barriers or challenges to accessing those services; and

  • understand the women’s needs and assess whether the referral services met those needs.

At each Phase 3 study site, staff developed specific strategies to ensure that women who tested positive were provided with referrals to local clinics, hospitals, and nongovernmental organizations for counseling, CD4 counts, and antiretroviral treatment, as necessary.

The Population Council conducted a qualitative research study at the three clinical trial sites in South Africa—the Setshaba Research Centre in Soshanguve (University of Limpopo/Medunsa campus), the Empilisweni Centre for Wellness Studies in Gugulethu (University of Cape Town), and the Isipingo Clinic (South African Medical Research Council, Durban). This study documented the referrals made and assessed the participants’ use of and satisfaction with these referrals.

The study consisted of in-depth interviews with HIV-positive women and a survey among providers and program staff in the established “referral network.”

Researchers conducted the interviews with 20–30 women at each site within ten to twelve weeks of their HIV-positive diagnoses. Researchers also conducted a survey among providers (including doctors, nurses, and counselors, as applicable) in the established “referral network” facilities to document the number of clients referred to each facility, identify the availability and use of different types of services that are offered at these facilities, and assess how referrals from the Phase 3 study contributed to the caseloads at these facilities.

A better understanding of the use and quality of services provided in referral networks will provide valuable data for the modification or revision of strategies for providing care and support for HIV-positive participants in this trial as well as other trials of HIV-prevention technologies.


Locations

Isipingo, Gugulethu, and Soshanguve, South Africa

Duration

April 2006–June 2007

Population Council researchers

Barbara Friedland, Sharon Abbott

Non-Council collaborators

Smruti Patel, Jane Harries (Women’s Health Research Unit, University of Cape Town)

Nazira Cassim, Khatija Ahmed, Vuyelwa Mtimkulu (University of Limpopo/Medunsa campus, Soshanguve)

Thesla Palanee, Neetha Morar (HIV Prevention Research Unit, South African Medical Research Council, Durban)

Donors

International Partnership for Microbicides

US Agency for International Development



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This page updated
18 February 2008


   

What's New

Senior microbicides researchers David Phillips and Robin Maguire retire. (more)

Council selects Louise Pedneault clinical director, microbicides, HIV and AIDS program (more)

Presentations by Council researchers at the Microbicides 2008 conference in New Delhi are now available. (more)

"Disappointment in trials another lesson," 26 February 2008 op-ed from The Star, South Africa (posted with permission) (PDF)

The results of the Phase 3 Carraguard® trial have been announced. (more)

For fact sheets and other resources about the Carraguard trial, click here.

"Benefits of the Population Council's microbicides program and Phase 3 Carraguard trial" (2008) (PDFs: A4 and letter)

"Day of dialogue—Insights and evidence from product introduction: Lessons for microbicides" (2007) (PDF)

"Ethics in clinical trials: Population Council's microbicides program," describes the Council's efforts to ensure microbicide research is ethical and transparent. (PDF)

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Publications/Resources

"Preferences and practices related to vaginal lubrication: Implications for microbicide acceptability and clinical testing" (2005) (abstract)

The Council has a fact sheet for those seeking additional information about the Carraguard trials: "The Population Council, HIV and AIDS, and microbicides" (full text) (PDF)

"Developing and testing a gel to prevent HIV transmission" (2005) (full text)

More