Positive deviance for dual-method promotion among women in Uganda: study protocol for a cluster randomized controlled trial

In sub-Saharan Africa (SSA), women of reproductive age bear a disproportionate burden of unintended pregnancies and sexually transmitted infections (STIs) including human immunodeficiency virus (HIV) [1]. In SSA, an estimated 29% of pregnancies are unintended [2]. Moreover, women account for approximately 56% of all adults living with HIV in this region [3]. This gender disparity starts when women reach their reproductive age, and women represent 59% of new HIV infections in this region [3, 4].

Unintended pregnancies occur because appropriate methods of contraception are not available or avoided [5]. To prevent this, highly effective contraceptives (HECs), such as hormonal contraceptives (e.g. pills, injectables, and implants), non-hormonal intrauterine device (IUD), and sterilization, were introduced to family planning programs [5]. In many countries in SSA, women have started to use these methods more frequently in recent decades [6]. HECs are effective in preventing unintended pregnancies but cannot prevent HIV/STIs [7]. Therefore, women need to protect themselves from HIV/STIs, regardless of whether they are using HECs or not.

Dual protection is defined as protection against the dual risks of unintended pregnancies and HIV/STIs [8]. It can be accomplished by either using a condom consistently alone or with HECs (dual-method use) [8]. Condoms are an effective method for women of preventing HIV/STIs from their sexual partners [9]. However, as they are often used incorrectly and inconsistently, condoms can only prevent 85% of pregnancies [10]. Dual-method use, thus, has been recommended as the most reliable protection against the dual risks in couples who do not want a child or who want to delay childbirth [7, 8, 11, 12]. Nevertheless, it remains uncommon [11]. In the United States, 7% of reproductive-age women who were sexually active used this method [13]. In SSA, most research has focused on dual-method use among women living with HIV and adolescents. For instance, 16% and 39% of women living with HIV practiced dual-method in 3 months in Ethiopia and Kenya, respectively [8, 14], while 7% of South African adolescents aged 15–24 years reported dual-method use [15].

A trade-off between HEC and use of condoms is a barrier to practicing dual protection. Women are less likely to use condoms with their male partners when using HECs [16]. Use of condoms may become unacceptable, especially in marital sex, as it is perceived as protection against HIV/STIs rather than pregnancies. Both women and men may think condoms are unnecessary with an intimate partner, especially when women are using HECs. However, use of condoms is necessary for women who are at risk of HIV/STIs, regardless of use of HEC [17, 18]. Extramarital sexual relationships are common, especially among men, in SSA [19]. For instance, an estimated 44% of HIV infections occurred among married or cohabiting couples in Kenya [20].

Several interventions have been conducted to promote dual-method use in the USA [11, 12]. However, few interventions had a significant effect on dual-method use [11, 12, 21] and the impact of such interventions was often not sustainable [22]. In resource-limited settings, including SSA, no interventions have been examined, although people are at considerable risk of unintended pregnancies and HIV/ STIs [11]. Women and men may perceive the importance of the use of condoms for preventing HIV/STIs, but often do not practice it [23]. Motivating factors for dual-method use remain unknown when the percentage of such users is low.

The positive deviance approach has the potential to address barriers to sensitive issues such as sexual and reproductive health. This approach seeks behaviors that contribute to otherwise high-risk individuals, or positive deviants, remaining free from a disease or condition and enables communities to adopt such practices [24, 25]. This approach has addressed complex development challenges, which are often hard for expert outsiders to measure, such as gender-related and socio-cultural barriers [24]. For example, the positive deviance approach was applied to advocate against female genital mutilation using actual words of positive deviants in Egypt [24]. Use of condoms is not prevalent in SSA, especially among married women using HECs. Barriers to condom use are complex and it is often difficult for outsiders to grasp the whole picture [26]. Given the limited effect of previous interventions [11], the positive deviance approach could be an ideal option for promoting dual-method use.

The present article illustrates a study protocol to examine the effect of an intervention formulated under the positive deviance approach on dual-method use among married women using HECs with their partners in Uganda.

The present study will be a unique trial to examine the effect of the intervention to promote dual-method use among women using the positive deviance approach. Dual-method use can reduce unintended pregnancies and HIV/STIs among women of reproductive age. Use of condoms is necessary for dual protection but is not commonly practiced in SSA, especially among married couples [9].

The present trial could tackle barriers to dual-method use, which expert outsiders may fail to recognize, by taking the positive deviance approach. This approach could be an ideal option when a problem needs behavioral change but is not merely technical [48]. The present study focuses on women who have already adapted the dual method and identifies unique effective communication and behavioral strategies that are actually working. Their unique solutions are analyzed and promulgated to other women who do not practice dual-method use. Unlike the usual approach, which looks for solutions from the outside, this approach could overcome barriers to dual-method use and bring sustainable effects by adopting local solutions. The present trial aims to provide evidence that the positive deviance approach can tackle not only dual-method use but also other issues that usual approaches have failed to address, by making use of local wisdom and solutions in Uganda.

The present study has several limitations. First, the success of the positive deviance approach depends on whether women practicing dual-method use or positive deviants can be found in the study area [24, 48]. Considering the prevalence of such people, the sample size can be too small and may need to be modified. Second, positive deviants are identified by the research team not by community members in this trial. Therefore, the effect of the intervention can be limited in mobilizing and empowering communities to adopt identified strategies, compared to the usual approach including self-discovery of positive deviants [24, 48]. Third, high attrition is anticipated, especially among women in the control arm, as all the interventions and follow-ups after recruitment and initial counseling are phone-based [11]. The present trial, therefore, calculated the sample size considering a relatively high attrition rate to offset potential losses to follow-up. Moreover, it will be minimized by building rapport with participants. For this, each participant will be contacted by the same positive deviant and/or research assistant for counseling and follow-up throughout the study period. Fourth, the outcomes will be assessed based on self-reports from participants and thus subject to response bias. Dual-method use can be over-reported while the incidence of STIs and unintended pregnancies can be under-reported due to social desirability bias. However, response bias will be minimized by assuring each participant of confidentiality of responses at the enrollment. Lastly, findings of the present study might lack external validity to other locations as it will focus on one particular community under the positive deviance approach [48]. In the present study, participants will be recruited in only public health facilities; thus, findings from this study may not be generalized to all women using HECs. To apply findings and the interventions developed in the present study to other areas and populations, further research will be necessary to assess its effectiveness in a given context.

The proposed research is designed to add evidence to the effectiveness of the positive deviance approach in tackling problems that the usual approach has failed to address, such as dual-method use. The results will be useful for public health policymakers to develop programs to reach women who need to tackle unintended pregnancies and HIV/STIs as well as other health problems that other solutions fail to address.