Suppositories

The Partner Project was a randomised study that recruited 420 HIV-seroconcordant and serodiscordant Zambian couples 18 years of age or older between January 2003 and June 2006. Of these, both partners participated and completed a baseline assessment of sexual and demographic data. A total of 392 couples were assessed from which additional analyses were conducted utilising data from a sample of participants with less than consistent condom use (N=83 couples). Couples were excluded if they reported no sexual activity within the last month.
Study candidates currently in heterosexual couple relationships were recruited from VCT clinics in the University Teaching Hospital, community health centres and non-governmental organisations. Randomisation was used to distribute the influence of VCT across both conditions. Couples were enrolled following HIV counselling and testing and provided verification of seropositive status of one or both members of the couple. Couples were screened for eligibility, i.e. currently sexually active, 18 years or older, couple relationship (minimum of 6 months as a couple to reduce potential attrition due to separation), and at least one member HIV seropositive.
Recruiters, assessors and interventionists were multilingual (e.g. Bemba, Nyanja, English) and assessments were conducted in the preferred language of the participant; the majority of assessments were conducted in English. Intervention sessions were conducted using a combination of Bemba, Nyanja and English, due to the mixture of audience language (73 local and 3 primary regional languages in Zambia); all study staff were fluent in the three intervention languages. All participants received monetary compensation for their travel expenses.
Participants (i) completed an informed consent; (ii) were tested for other sexually transmitted infections (STDs; HIV, antibody test, syphilis, serum; chlamydia and gonorrhoea, Gram stain) and vaginal infections (bacterial vaginosis, candidiasis, trichomonas), and penile infections; (iii) completed a baseline assessment of demographic information and sexual behaviour; and (iv) were randomised to condition (see Fig. 1).
All sessions were gender-concordant groups. All female participants completed the multiple (3) session intervention; their male partners were randomised into multiple (3) session and single (1) session group intervention arms to assess the relative influence of increased participation by male partners on sexual risk reduction within the couple. Both arms were introduced to and provided with the same number of male (18) and female (6) condoms per couple; multiple session group intervention participants were also provided with a lubricant pack of three vaginal lubricants to serve as placebos to assess product acceptability for future potential introduction of microbicides (Astroglide® & KY® gels, Lubrin® suppositories). Participants were notified of their STD or screening results and were provided with appropriate treatment prior to receiving study products. For those participants who were lost to followup, recruiters conducted home visits in the community to encourage study involvement and if the participant withdrew, establish the reason for attrition. In the event of permanent loss of one member of a couple (e.g. illness, death, estrangement), individual participants were encouraged to continue to participate. The primary causes for attrition over 12 months (15%) were moving to another location, (75%) employment, (10%) illness, (5%) divorce, and death (5%).