Research Questions and data source
Would a vaginal microbicide gel be an acceptable long term HIV prevention option to women and men if an effective microbicide is identified?
Specifically, the questions were aimed to:
(i) Assess the reliability and validity of the data in the CRF on the frequency of sex, gel and condom use, anal sex, douching and the insertion of various products into the vagina;
(ii) Inform understanding patterns of disclosure: why participants inform or do not inform their partners that they are using gel, and the process in which they negotiate gel use with their partners;
(iii) Assess the acceptability of gel use among females and males and the community perception of a HIV prevention vaginal gel, and;
(iv) Assess the informed consent procedure and checking whether the participants have understood key aspects of the trial.
Fit within AC portfolio
The MDP301 social science component forms part of the ‘HIV dynamics: understanding the HIV epidemic’ portfolio by providing further information about the sexual behavior and norms of HIV negative women of reproductive age. It also provides an opportunity to understand more about women’s’ responses to HIV prevention clinical trials.
Methods and Data source
This work was carried out as part of the MDP clinical trial which evaluated the effectiveness of Pro2000 vaginal microbicide in preventing acquisition of HIV infection. Coital diaries were completed by a sub-sample of trial participants. In-depth interviews were conducted with the same sub-sample of trial participants and a selection of their male partners. Focus group discussions were conducted with trial participants (not included in the in-depth interviews) and community members. The coital diaries were data captured in the main MDP 301 database using an Access application with a SQL Server database. Qualitative recordings were transcribed in isiZulu, translated into English and imported into the NVivo 7 qualitative software package for coding and analyses.
Findings:
Volunteers in a microbicide trial in KwaZulu-Natal: a comparison with the general population
We compared 810 women who volunteered for the Microbicides Development Programme (MDP) clinical trial in KwaZulu-Natal, with 14,855 women in the same community living in the Africa Centre demographic surveillance area. In multivariable analysis, there were no statistically significant differences between MDP trial volunteers and ACDIS women in terms of employment status, household access to electricity or ownership of a radio, fridge, motorbike or cattle. MDP trial volunteers were younger than ACDIS women, with a median age of 31 years compared to 33 and had a lower overall level of education, although 54% of both samples had some secondary education. MDP women lived in households that were more likely to own a bicycle, but less likely to own a phone or television. MDP women appeared to have higher status within their household than ACDIS women.
Re-Framing Microbicides Acceptability: Findings from the MDP 301 Trial
Microbicides have predominantly been conceptualised within a disease prevention framework and studies usually define acceptability in terms of product characteristics, willingness to use, and risk reduction. This starting point has led to assumptions about microbicides which, rather than being challenged by empirical studies, have tended to foreclose the data and subsequent conceptual models. Few studies consider an emic perspective or attempt to understand how microbicides fit into the broader meaning and structures of women’s and men’s everyday lives. As part of the integrated social science component of the MDP301 Phase III microbicide trial, in-depth interviews were conducted with a random sub-sample of female trial participants. In an analysis of data from 464 women at six sites in South Africa, Zambia, Tanzania and Uganda, we find that women’s experiences of the gel challenge several assumptions that have commonly been reiterated about microbicides. While all women knew that the purpose of gel was to prevent HIV infection, this was but one of several meanings that gel acquired as they used it. Increased sexual pleasure, function and libido were prominent in women’s accounts, and linked to this was a sense of security and wellbeing. Women also perceived their health to have improved, and attributed the curing of discharge, itching and other ailments to the gel. Although covert use had been posited in the literature as a key advantage of microbicides, most women wanted to involve their partners in using the product, and many men were supportive. “Dry sex” practices did not pose a barrier to acceptability, as had been assumed.
Should a moderately protective microbicide be made available in communities with high HIV incidence? Opinions of potential end-users from a rural South African community
To assess the views of potential end users of 0.5% PRO2000/5 microbicide in KwaZulu-Natal on a level of effectiveness that would justify a licensure application in South Africa, assuming that PRO2000/5 demonstrates a statistically significant reduction in HIV incidence, Focus Group Discussions were conducted with local staff members of a phase III microbicide clinical trial, former trial participants and Community Advisory Board members not enrolled in the trial. Respondents stated that even a moderately protective HIV prevention option that is highly acceptable would be an important addition to condoms for women; that a moderately protective microbicide would have to be introduced as part of the existing prevention messages in order to avoid a reduction in condom use; that there should eventually be a choice between ARV-based and non-ARV based microbicides (driven by their knowledge of side effects with therapeutic ARVs), and a choice of how and where to access microbicides; and that it would be important to plan for access to a microbicide that can offer moderate protection rather than wait to find out if alternative microbicides are equally or more effective.
Intravaginal insertion in KwaZulu-Natal: new insights into sexual practices and preferences in the context of microbicide gel use
Intravaginal insertions are often associated with the concept of ‘dry’ sex. All HIV prevention microbicides tested to date have been vaginally applied lubricant-based gels. In this paper we examine whether the use of intravaginal insertions could be in conflict with the introduction of vaginal microbicide gels. We conducted in-depth-interviews and focus group discussions with women enrolled in the trial as well as women and men from the community. Intravaginal use of a variety of products was widely acknowledged. We found that the experience of using trial gels - ‘hot’, ‘tight’ and ‘dry’ sex – matched the desired outcomes of intravaginal insertion. We found that vaginal ‘dryness’ described the removal of excessive amounts of unusual discharge, rather than the removal of normal vaginal secretions, and that intravaginal insertions are not exclusively associated with a desire for ‘dry’ sex. Our study provides evidence that vaginal microbicide gels may be more acceptable in communities where intravaginal insertion is practiced than was previously thought.
“One Teabag is better than Four”: Participants response to the discontinuation of 2% PRO2000/5 microbicide gel in KwaZulu-Natal, South Africa
The Microbicides Development Programme (MDP) 301 clinical trial evaluated the safety and effectiveness of 0.5% and 2% PRO2000/5 microbicide gels in reducing the risk of HIV infection for women. In February 2008 the Independent Data Monitoring Committee recommended that evaluation of 2% PRO2000/5 gel be discontinued due to futility. The Africa Centre site systematically collected participant responses to this discontinuation. Clinic and field staff completed field reports using ethnographic participant observation techniques. In-depth-interviews and focus group discussions were also conducted with participants discontinued from 2% gel. A total of 72 field reports, 12 in-depth-interviews and 3 focus groups were completed for this analysis. Participants responded initially with fear that discontinuation was due to harm, followed by acceptance after effective messaging, and finally with disappointment. Participants reported that their initial fear was exacerbated by being contacted and advised to visit the clinic for information about the closure. As a result, operational changes were made to the contact procedures. By incorporating feedback from participants, messages were continuously revised to ensure that information was comprehensible and misconceptions were addressed quickly thereby enabling participants to accept the discontinuation. Participants were disappointed that 2% PRO2000/5 was being excluded as a HIV prevention option, but also that they would no longer have access to gel that improved their sexual relationships with their partners and assisted in negotiating condom use. In total 238 women were discontinued from gel and 185 (78%) completed their scheduled follow-up period.