Hoke TH, Feldblum PJ, Damme KV, Nasution MD, Grey TW, Wong EL et al. Randomised controlled trial of alternative male and female condom promotion strategies targeting sex workers in Madagascar. Sex Transm Infect. 2007 Oct;83(6):448-53.
To assess whether individual clinic-based counseling as a supplement to peer education for male and female condom promotion leads to greater use of protection and lower STI prevalence among sex workers in Madagascar already exposed to intensive male condom promotion.
Randomized controlled trial. This study is the second randomization phase of a two-phased trial whose initial phase was previously reported.(1)
Two public sector clinics in Antananarivo and Tamatave, Madagascar.
1000 self-identified female sex workers were randomized in the initial phase and the 901 participants who completed the 6-month first phase were randomized again for phase 2. Eight hundred sixty-three women provided STI data at 12 months of follow-up, 818 at 18 months. Mean participant age was 27 to 31 years across the sites and intervention groups. Most Antananarivo participants were divorced or separated but currently in a stable union. Slightly fewer Tamatave participants reported having a steady boyfriend, and no participants reported cohabitation.
The initial phase of the trial examined rates of protected sex and STI prevalence among sex workers exposed to male condom promotion through peer education alone or peer education supplemented with clinic based counseling. In the second phase, male and female condoms were provided at the same price and counseling provided for both methods. Participants were again randomized to receive prevention counseling by peer educators or by both peers and bi-monthly clinic-based counseling, delivered by a nurse in Tamatave and a physician in Antananarivo who were both trained by a consultant specializing in behaviour change communication. Both groups were followed for 12 months. Counseling took place while the peer educators accompanied their assigned participants to bi-monthly interviews at the clinics and during ad hoc contacts in the community. The 15-minute clinic counseling sessions involved two-way exchange of information concerning individual risk assessment; transmission and verification of basic knowledge about STI/HIV; dual protection; demonstration of use of both types of condoms with opportunity to practice using models; reinforcement of skills for negotiating condom use; and promotion of the "no condom = no sex" policy. Clinicians offered sample male and female condoms and advised participants to purchase additional condoms from a peer educator (Tamatave) or a social marketing agent (Antananarivo).
At each bi-monthly visit (6, 8, 10, 12, 14, 16, 18 months), participants were interviewed about their sexual activity and condom use with clients (paying sexual partners) in the last 30 days and non-paying partners (last act). Participants were tested and treated for chlamydia, gonorrhoea and trichomoniasis.
Primary outcomes were STI prevalence from vaginal swab and urine sample at 6, 12 and 18 months and condom use with clients and non-paying partners.
There was no statistically significant association between study arm and the aggregate STI outcome (OR=1.09, 95%CI=0.81 to 1.48). Site-specific results were also not statistically significant (OR=0.82, 95%CI=0.55 to 1.22 at Atananarivo and OR=1.54, 95%CI=1.00 to 2.38 at Tamatave). Mean proportion of sex acts with clients in the past 30 days in which protection was used, stratified by intervention group and site, increased over time in all four groups, increasing from 76-82% at Phase I (month 6) to 84-91% of acts following 12 months of male and female condom promotion (month 18). Antananarivo participants receiving peer education alone achieved the steepest increase during phase 2. The Tamatave peer+clinic group showed the most modest increases in reported use of protection. The proportion of participants reporting any use of the female condom with a paying partner in the past 30 days was greater among Antananarivo participants, with no important differences between intervention groups. For three of the four intervention- and site-specific groups, the proportion of study participants reporting use of protection in their last sex act with a non-paying partner held steady throughout 12 months of female condom availability, never surpassing the level of protection achieved at the end of the male condom-only phase. The exception was the Antananarivo peer+clinic group, showing a 10% increase in the proportion of participant reporting use of protection in their last act with a non-paying partner.
Peer promotion of male and female condom use to a sex worker population appears as effective as a more intensive clinic-based counseling intervention for encouraging use of barrier protection. The authors suggest that these findings indicate that less clinically intensive interventions such as peer education could be suitable for male and female condom promotion in populations already exposed to barrier method promotion.
Based on the Jadad scale for quality of randomized trials, this trial receives a score of 3 (5 maximum score). Study arms were randomized, randomization was briefly described, and loss-to-follow up was noted. The authors report that due to a programming error, the second round of randomization was inadvertently imbalanced, with a disproportionately high number of participants who received the more intensive intervention in the first phase receiving the more intensive intervention in the second phase. Loss-to-follow up was noted, however reasons for participants being lost to follow-up were not described. Four study participants did not receive their assigned allocation at Phase 2, but were included in their assigned study arm during analyses (intent-to-treat analysis). Of the 901 participants originally enrolled in Phase 2 of the study, 818 women completed a study visit at 18 months. Additionally, while clinic staff and participants were not blinded to group assignment, laboratory staff were blinded. Limitations of the trial include potential over-reporting of condom use due to self-reporting and differential social desirability bias in the study arms. Unblinded participants in the treatment arm may have been especially prone to over-report condom use. A potential limitation of the STI results is the lack of certainty about treatment effectiveness. With close participant follow-up and highly effective treatment, the authors presumed infections were resolved at the start of each study phase. To the extent infections did not clear with treatment in the previous phase, actual prevalence of new infections might be lower than reported. This effect would be equivalent across study groups, however, and should not affect the study outcomes.
Recently, selected STI prevention programs targeting sex workers have added female condom distribution to their services.(2,3,4) In some settings, availability of this female initiated method in addition to male condoms has been associated with increased levels of protection.(5,6,7,8,9) However, the strategies necessary for successful female condom promotion are still uncertain. Previously documented interventions involving the female condom have included multiple components with repeated educational sessions delivered by professionals in health facilities. The authors suggest that the replicability and sustainability of these intensive promotion strategies are limited in resource-poor settings where the need for STI prevention options is most dire. The current study is one of few randomized trials to compare alternative strategies for simultaneous promotion of male and female condom use. The study's first phase, conducted with the same cohort, revealed higher rates of protected sex and lower STI prevalence among sex workers exposed to clinic based counselling as a supplement to peer education, in the presence of male condom promotion only.1 One possible explanation for the ineffectiveness of the more intensive clinic-based intervention in phase 2 is that participants could have been already maximally convinced of the importance of consistent use of protection and skilled in negotiating for use of protection after 6 months of male condom promotion in phase 1. Alternatively, the authors posit that the instruction required for mastery of a new method such as the female condom could be minimal compared to the coaching required for successful use of barrier method protection in general. Therefore, introducing the female condom into prevention programs with strong, ongoing male condom promotion may be particularly expedient.
The authors suggest that interventions for introducing female condoms might not need to be particularly intensive in populations that are already well exposed to male condom promotion and have adopted preventive behaviours. Lay health workers or peer educators could potentially play an important role in encouraging male and female condom use, thereby freeing clinicians to attend to other STI control interventions such as diagnosis and treatment. This is particularly relevant for settings with healthcare manpower shortages where clinicians' time is needed elsewhere.
- Feldblum PJ, Hatzell T, Van Damme K, Nasution M, Rasamindrakotroka A, Grey TW. Results of a randomised trial of male condom promotion among Madagascar sex workers. Sex Transm Infect 2005 Apr;81(2):166-73.
- French PP, Latka M, Gollub EL, Rogers C, Hoovers DR, Stein ZA. Use-effectiveness of the female condom versus male condom in preventing sexually transmitted diseases in women. Sex Transm Dis 2003 May;30(5):433-9.
- Fontanet AL, Saba J, Chandelying V, Sakondhavat C, Bhiraleus P, Rugpao S et al. Protection against sexually transmitted diseases by granting sex workers in Thailand the choice of using the male or female condom: results from a randomized controlled trial. AIDS 1998 Oct 1;12(14):1851-9.
- Welsh MJ, Feldblum PJ, Kuyoh MA, Mwarogo P, Kungu D. Condom use during a community intervention trial in Kenya. Int J STD AIDS 2001 Jul;12(7):469-74.
- Thomsen SC, Ombidi W, Toroitich-Ruto C, Wong EL, Tucker HO, Homan R et al. A prospective study assessing the effects of introducing the female condom in a sex worker population in Mombasa, Kenya. Sex Transm Infect 2006 Oct;82(5):397-402.
- Musaba E, Morrison C, Sunkutu MR, Wong EL. Long-term use of the female condom among couples at high risk of human immunodeficiency virus infection in Zambia. Sex Transm Dis 1998 May;25(5):260-4.
- Latka M, Gollub E, French P, Stein Z. Male-condom and female-condom use among women after counseling in a risk-reduction hierarchy for STD prevention. Sex Transm Dis 2000 Sep;27(8):431-7.
- Hoffman S, Mantell J, Exner T, Stein Z. The future of the female condom. Perspect Sex Reprod Health 2004 May-Jun;36(3):120-6.
- Artz L, Macaluso M, Brill I, Kelaghan J, Austin H, Fleenor M et al. Effectiveness of an intervention promoting the female condom to patients at sexually transmitted disease clinics. Am J Public Health 2000 Feb;90(2):237-44.