Exploring a community's understanding of HIV vaccine­induced seropositivity in a South African research setting.

BACKGROUND: The high HIV prevalence and incidence in South Africa makes it suitable for recruitment of participants for large-scale HIV preventive vaccine trials. However, fear of vaccine-induced seropositivity (VISP) may be a barrier for community acceptability of the trial, for volunteers to participate in HIV preventive vaccine trials and for uptake of an efficacious vaccine. Prior to 2015, when the first phase 1 safety HIV vaccine trial was undertaken at Setshaba Research Centre, Soshanguve, the local community stakeholders and healthcare workers were naive about HIV vaccine research and HIV preventive vaccines. OBJECTIVE: To explore knowledge and perceptions regarding VISP among community stakeholders and healthcare workers in peri-urbanb Soshanguve, Tshwane. METHODS: Using a quantitative-qualitative mixed-methods study design, surveys (n=50) and in-depth interviews (n=18) were conducted during July - August 2015. Participants included community stakeholders, community advisory board members and healthcare workers, who were >18 years old and had attended community educational workshops during September 2014 - May 2015. Audio recordings of interviews were transcribed verbatim and coded using content thematic analysis. Data were further analysed by sex, age and educational level. RESULTS: Of a maximum score of 2 on knowledge on VISP, the 50 survey participants (mean age 33.78 years; 45 females) obtained an average of 0.88 (44%). Of 17 in-depth interviewees (one interview could not be transcribed; mean age 30.9 years; 12 females), 8 (47%) displayed some knowledge about VISP, of whom only 5 defined VISP correctly. Women were more knowledgeable about VISP than men; 5 of 12 women (42%) came close to defining VISP correctly, while none of the 5 men did so. The main fear of trial participation expressed by most participants (n=6) was testing HIV-positive as a result of the vaccine. While some participants believed that the community's perceptions of VISP would negatively affect HIV vaccine trial support and recruitment efforts, others noted that if trial participants understand the concept of VISP and are part of support groups, then they would have the information to combat negative attitudes within their community. CONCLUSION: Most participants had an inaccurate and incomplete understanding of VISP. Many feared testing HIV-positive at clinics; therefore, education on improving a basic understanding of how vaccines work and why VISP occurs is essential. In addition, assessing participant understanding of HIV testing, transmission and VISP is critical for recruitment of participants into HIV vaccine trials and may improve acceptability of an HIV preventive vaccine.

The role of partnership dynamics in determining the acceptability of condoms and microbicides.

Microbicides are a class of substances under development that could reduce the sexual transmission of HIV and other sexually transmitted diseases when applied locally to genital mucosal surfaces. Microbicide acceptability research has largely focused on product characteristics, rather than processes of negotiation within relationships about use. Gender relations, decision-making power and communication within sexual relationships are recognised as important determinants of condom and contraceptive use, and are likely to determine microbicide use also. As part of social science research linked to the Microbicides Development Programme (MDP) we combine relationship-based theories with anthropological work conducted with women and men using a placebo gel. We explore communication and decision-making in gel and condom use, including constructions of risk and trust. During the MDP301 Phase III pilot study, in-depth interviews were conducted at sites in South Africa, Tanzania, Uganda and Zambia. Following four weeks of placebo gel use, women and their partners were asked about gel use and acceptability, partner involvement, sexual practices and condom use. Data from 45 couples at five sites were analysed using a grounded theory approach in NVivo. Participation in the study did not require women to inform their partners, yet our data shows women seeking permission from their partners, negotiating disclosure, exchanging information and persuading or motivating for gel use. Although gel was supposedly 'woman-controlled', men exercised considerable influence in determining whether and how it was used. Despite this, negotiations around use were largely successful, since the gel increased sexual pleasure and provided opportunities for intimate communication and the building of trust. Decisions about condom and microbicide use are made in a dyadic context and involve a complex negotiation of risk and trust. Whilst preferences relating to product characteristics are largely individual, use itself is dependent on partnership dynamics and the broader social context in which sexual risk management occurs.

Challenges in the conduct of vaginal microbicide effectiveness trials in the developing world.

Conducting a phase III trial of a vaginal microbicide in a developing country poses several important and complex ethical challenges. As part of a process to bridge the gap between ethical theory and practice, we share our experiences in performing a phase III trial of Col 1492 (Advantage S) among female sex workers at four sites world-wide; Durban, Abidjan, Cotonou and Hat Yai. The ethical challenges included: (i) difficulties in obtaining informed consent. Participants were unable to grasp the concepts of a clinical trial for several weeks to months. In Cotonou, 30% of the women did not know the gel was tested for HIV prevention. Only 25% understood what a placebo was. In Durban, 70% of the women did not fully understand the study after 3 months; (ii) in sustaining the use of known HIV prevention strategies. Participants at the Durban site had difficulty in sustaining condom use due to financial and client preferences. Sex without condoms was worth more ($20) than sex with condoms ($10); (iii) in maintaining the confidentiality of the subject's HIV status. Novel approaches such as role plays and emphasis on other exclusion criteria were needed to maintain the confidentiality of women not included in the trial due to their HIV status; (iv) in providing care and support to the subjects who became infected with HIV during the trial. Women could only be offered routine sexually transmitted disease treatment and counselling. Anti-retrovirals were not offered. The successes and failures of the solutions attempted are described.

Recording sexual behavior: comparison of recall questionnaires with a coital diary.

OBJECTIVE: To compare sexual behavior data obtained using a weekly-recall questionnaire, a daily-recall questionnaire, and a coital diary. DESIGN: Cross-sectional survey of female sex workers from KwaZulu-Natal, South Africa between August and October 1998. METHODS: In this study, 52 weekly-recall questionnaires, 27 daily-recall questionnaires, and 79 coital diaries for dates corresponding to the questionnaires were obtained from female sex workers. Variables examined included: number of clients, number of condoms used with clients and partners, and number and type of sexual acts with clients and partners. Statistical analyses were conducted to examine the degree of agreement between the data collection methods and to assess differences between the mean values of the variables in the questionnaires versus the diary. RESULTS: Comparison of weekly-recall questionnaires with coital diaries indicated a significantly greater mean number of clients (P < 0.001), number of condoms used (P < 0.001), vaginal acts (P < 0.001), and anal acts (P = 0.044) reported in the diary versus the questionnaire. On comparison of daily-recall questionnaire with coital diary, significant differences were revealed between the means detected for the number of clients (P = 0.027), number of days worked (0.009), and anal acts with clients (P = 0.004). CONCLUSIONS: The use of coital diaries for the collection of sexual behavior data may be limited to cross-sectional community surveys. A recall questionnaire may provide more reliable and a better quality of data for longitudinal studies and for human immunodeficiency virus/sexually transmitted disease evaluation programs.

PIP: This study aimed to compare data obtained from coital diaries (CD) with those collected using weekly recall (WR) and daily recall (DR) questionnaires. 79 female sex workers aged 18-44 coming from KwaZulu-Natal, South Africa, were studied. They were followed up every month with clinical examination and treatment of STDs, provision of condoms, and CD collection. There were 52 WR, 27 DR, and 79 CD records collected from the participants. Results showed that CD records showed a significantly greater mean number of clients compared to the questionnaires (23.3 vs. 13.6, P 0.001), number of condoms used (2.7 vs. 0.5, P 0.001), vaginal acts (6.8 vs. 2.9, P 0.001), and anal acts (1.9 vs. 0.7, P = 0.044). Daily accounts of weekly sexual activity showed significant differences in 1) the number of days worked (6.2 vs. 5.2, P = 0.009), 2) the number of clients (21.7 vs. 17.4, P = 0.027), and 3) the number of anal acts with clients (3.9 vs. 0.8, P = 0.004), with higher means reported in the CD records for all cases. The CD records are an important instrument for gathering preliminary sexual behavioral information; however, their use is limited to long-term data collection. Therefore, a comprehensive recall questionnaire is recommended for future trials.