title: "One teabag is better than four": Participants response to the discontinuation of 2% PRO2000/5 microbicide gel in KwaZulu-Natal, South Africa.
abstract: BACKGROUND
  The Microbicides Development Programme evaluated the safety and effectiveness of 0.5% and 2% PRO2000/5 microbicide gels in reducing the risk of vaginally acquired HIV. 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.
  
  
  METHODS
  Clinic and field staff completed field reports using ethnographic participant observation techniques. In-depth-interviews and focus group discussions were conducted with participants discontinued from 2% gel. A total of 72 field reports, 12 in-depth-interviews and 3 focus groups with 250 women were completed for this analysis. Retention of discontinued participants was also analysed. Qualitative data was analysed using NVivo 2 and quantitative data using STATA 10.0.
  
  
  RESULTS
  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. Operational changes were subsequently 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 condom negotiations. In total 238 women were discontinued from gel and 185 (78%) went on to complete their scheduled follow-up period.
  
  
  CONCLUSIONS
  The use of qualitative social science techniques allowed the site team to amend operational procedures and messaging throughout the discontinuation period. This proved instrumental in ensuring that the discontinuation was successfully completed in a manner that was both understandable and acceptable to participants.
  
  
  BACKGROUND
  Current Controlled Trials. ISRCTN64716212.
authors.affiliation: Africa Centre for Health and Population Studies, University of KwaZulu-Natal, South Africa. mgafos@africacentre.ac.za
authors.forename: Mitzy
authors.initials: M
authors.lastname: Gafos
authors.forename: Misiwe
authors.initials: M
authors.lastname: Mzimela
authors.forename: Hlengiwe
authors.initials: H
authors.lastname: Ndlovu
authors.forename: Nkosinathi
authors.initials: N
authors.lastname: Mhlongo
authors.forename: Yael
authors.initials: Y
authors.lastname: Hoogland
authors.forename: Richard
authors.initials: R
authors.lastname: Mutemwa
mesh_terms: D000282:Administration, Intravaginal; D000890:Anti-Infective Agents / Q000627:therapeutic use*; D000891:Anti-Infective Agents, Local / Q000627:therapeutic use; D003625:Data Collection; D005260:Female; D005782:Gels; D015658:HIV Infections / Q000517:prevention & control*; D006801:Humans; D018447:Medical Futility; D009282:Naphthalenesulfonates / Q000627:therapeutic use*; D011108:Polymers / Q000627:therapeutic use*; D058028:Research Report; D013019:South Africa
chemical_list: D000890:Anti-Infective Agents; D000891:Anti-Infective Agents, Local; D005782:Gels; D009282:Naphthalenesulfonates; C120231:PRO 2000; D011108:Polymers