title: Uptake of hormonal contraceptives and correlates of uptake in a phase III clinical trial in rural South Western Uganda.
abstract: BACKGROUND
  Use of a reliable contraception method has become an inclusion criterion in prevention trials to minimize time off product. We report on hormonal contraceptive prevalence, uptake, sustained use and correlates of use in the Microbicides Development Programme (MDP 301) trial at the Masaka Centre in Uganda.
  
  
  METHODS
  HIV negative women in sero-discordant relationships were enrolled and followed-up for 52 to 104 weeks from 2005 to 2009. Contraceptive use data was collected through self-report at baseline and dispensing records during follow-up. Hormonal contraceptives were promoted and provided to women that were not using a reliable method at enrolment. Baseline contraceptive prevalence, uptake and sustained use were calculated. Uptake was defined as a participant who reported not using a reliable method at enrolment and started using a hormonal method at any time after. Logistic regression models were fitted to investigate predictors of hormonal contraceptive uptake.
  
  
  RESULTS
  A total of 840 women were enrolled of whom 21 aged ≥50 years and 12 without follow-up data were excluded; leaving 807 (median age 31 IQR 26-38) in this analysis. At baseline, 228 (28%) reported using a reliable contraceptive; 197 hormonal, 28 female-sterilisation, two IUCD and one hysterectomy. As such 579 were not using a reliable contraceptive at enrolment, of whom 296 (51%) subsequently started using a hormonal contraceptive method; 253 DMPA, four oral pills, and two norplant. Overall 193 (98%) existing users and 262 (88%) new users sustained use throughout follow-up. Independent correlates of hormonal contraceptive uptake were: younger women ≤30 years, aOR = 2.5, 95% CI: 1.7-3.6 and reporting not using contraceptives at baseline due to lack of access or money, breastfeeding or other reasons, in comparison to women who reported using unreliable method.
  
  
  CONCLUSIONS
  Promotion and provision of hormonal contraception doubled the proportion of women using a reliable method of contraception. Uptake was pronounced among younger women and those not previously using a reliable method because of lack of access or money, and breastfeeding. Promotion and provision of hormonal contraceptives in trials that require the interruption or discontinuation of investigational products during pregnancy is important to reduce the time off product.
  
  
  BACKGROUND
  Protocol Number ISRCTN64716212 .
authors.affiliation: MRC/UVRI Uganda Research Unit on AIDS, P.O Box 49, Entebbe, Uganda. Andrew.Abaasa@mrcuganda.org.
authors.forename: Andrew
authors.initials: A
authors.lastname: Abaasa
authors.affiliation: MRC Clinical Trials Unit at UCL, London, UK.
authors.forename: Mitzy
authors.initials: M
authors.lastname: Gafos
authors.affiliation: MRC/UVRI Uganda Research Unit on AIDS, P.O Box 49, Entebbe, Uganda.
authors.forename: Zacchaeus
authors.initials: Z
authors.lastname: Anywaine
authors.affiliation: MRC Clinical Trials Unit at UCL, London, UK.
authors.forename: Andrew
authors.initials: A
authors.lastname: Nunn
authors.affiliation: MRC Clinical Trials Unit at UCL, London, UK.
authors.forename: Angela
authors.initials: A
authors.lastname: Crook
authors.affiliation: MRC/UVRI Uganda Research Unit on AIDS, P.O Box 49, Entebbe, Uganda.|Faculty of Health Sciences, School of Public Health, University of the Witwatersrand, Johannesburg, South Africa.
authors.forename: Jonathan
authors.initials: J
authors.lastname: Levin
authors.affiliation: MRC Clinical Trials Unit at UCL, London, UK.
authors.forename: Sheena
authors.initials: S
authors.lastname: McCormack
authors.affiliation: MRC/UVRI Uganda Research Unit on AIDS, P.O Box 49, Entebbe, Uganda.
authors.forename: Anatoli
authors.initials: A
authors.lastname: Kamali
mesh_terms: D000293:Adolescent; D000328:Adult; D003267:Contraception / Q000379:methods*; D003268:Contraception Behavior / Q000706:statistics & numerical data*; D003278:Contraceptives, Oral, Hormonal / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008875:Middle Aged; D011247:Pregnancy; D014454:Uganda; D055815:Young Adult
chemical_list: D003278:Contraceptives, Oral, Hormonal
keywords: Clinical trials; Contraceptive uptake; Hormonal contraceptives; Microbicides