A total of 137 pregnancies occurred during follow-up, and average follow-up time was 506.6 days. Women were 29 (SD = 6) years old on average, and men were on average 35 (SD = 7) years old. Couples had an average of 2 (SD = 1) living children, and Nyanja literacy was high and similar among baseline method users and nonusers. Most participants were of concordant positive serostatus (70% of baseline method nonusers and 63% of baseline method users). Roughly two-thirds of women and 58% of men did not want more children, regardless of baseline contraceptive use. Men were more likely to want more children, but not in the next year relative to women for both couples not using a contraceptive method at baseline (38% men versus 26% women) and baseline method users (36% men versus 29% women) (Table 1).
Roughly, half of women reported that the couple decided together whether or not to have more children, and roughly 30% reported that the men decided, regardless of baseline method use. In contrast, the majority of men reported that the couple decided together (77% of baseline nonusers and 78% for baseline method users). Among all women, 99% chose to use a modern contraceptive method after the intervention, and this was not different by trial arm (Table 2).
Among women who were not using a method at baseline, most (98%) chose to use a modern contraceptive method immediately after receiving the intervention, with 43% selecting injectables, 35% selecting OCPs, 14% selecting Norplant implant, 4% choosing the IUD, and 1% choosing tubal ligation. The proportion chosing the IUD was higher in the “Methods video” arm (6%, n = 24 versus 2%, n = 8; χ2 = 7.76, P = 0.005).
Among the 278 women using a modern contraceptive method before the intervention, the distribution of methods used was as follows: 174 (63%) OCPs, 91 (33%) injectables, 5 (2%) IUD, 8 (3%) Norplant implant. This distribution did not differ by trial arm (χ2 P = 0.261, data not shown). After viewing their assigned intervention videos and being offered the full range of contraceptive methods, 193 (69%) continued their previous method and 85 switched to another method including 2 (1%) tubal ligation, 48 (17%) injectables, 5 (2%) IUD, 28 (10%) Norplant implant, and 2 (1%) OCP. All 5 of the baseline method users who switched to the IUD had viewed the “Methods video.” The distribution of methods chosen was significantly different between those viewing the “Methods video” versus those not receiving the “Methods video” (P = 0.018) (Table 2).
Knowledge of OCPs, injectables, and, to a lesser extent, Norplant implant and IUD was high among all women, as these methods were presented in the IC signed by all participating couples.33 Relative to women using a method before the intervention, women who were not using a method had significantly less knowledge (either spontaneous or prompted) about Norplant implant (χ2 P = 0.0013), IUD, and vasectomy (χ2 P = 0.0246). Women who were not using a method before the intervention reported lower historical use of OCPs (χ2 P < 0.0001) and injectables (χ2 P < 0.0001) relative to women who were method users at entry into the study. Conversely, women using a method at baseline had significantly increased worries, concerns, or fears about OCPs (χ2 P < 0.0001) and injectables (χ2 P = 0.0002) relative to women not using a method at baseline (Table 2).
Effect measure modification by both couple serostatus (concordant positive, discordant man positive, and discordant woman positive) and use of a contraceptive method at entry in the study (before the intervention) were observed (P < 0.0001). No confounders (failures of randomization occurring by chance) were significant in multivariate Cox proportional hazards models among all couples, stratified by serostatus or stratified by use of a contraceptive method at entry; therefore, unadjusted models are presented. The proportional hazards assumption was met for all models.
Results from the Cox proportional hazards models showed that among couples in which the woman partner was not using a method at entry, there was no significant effect of the intervention on pregnancy incidence, even after stratifying by couple serostatus. Among couples in which the woman was already using a contraceptive method at the time of the intervention, those who viewed the “Methods video” had a significantly increased time to pregnancy relative to those who did not [11/118 versus 34/160; hazard ratio (HR) = 0.38; 95% CI: 0.19 to 0.75]. The effect size was highest in concordant positive couples who viewed the “Methods video” versus concordant positive couples who did not view the “Methods video” (HR = 0.22; 95% CI: 0.08 to 0.58), and couples in which the woman was HIV positive at baseline who viewed the “Methods video” versus couples in which the woman was HIV positive who did not view the “Methods video” (HR = 0.23; 95% CI: 0.09 to 0.55) (data not shown).
Log-rank tests from Kaplan–Meier survival curves were generated for each unadjusted model that also showed a significant intervention effect among couples who were using modern contraception at the time of study entry (Fig. 2). Among couples of all serostatus combinations, pregnancy incidence was significantly lower in those who had viewed the “Methods video” (Fig. 2A; log-rank χ2 = 8.45, P = 0.0036). Again, the association was strongest for concordant positive couples (Fig. 2B; log-rank χ2 = 11.38, P = 0.0007) and for couples with HIV-positive women (Fig. 2C; log-rank χ2 = 13.02, P = 0.0003).
Post hoc Analyses
Given that the intervention was successful among concordant positive couples, we evaluated the fertility intentions of concordant positive versus discordant couples in a post hoc analysis. Men in concordant positive relationships were more likely to not desire more children relative to men in discordant relationships (62% versus 49%; χ2 = 17.77, P = 0.0001). There was no significant difference in the distribution of women’s fertility intentions between concordant positive couples and discordant couples (χ2 = 1.75, P = 0.627), in which 68% and 67% of women did not desire more children, respectively (data not shown).
No harms or adverse events were associated with participation in this study.
This randomized controlled trial demonstrated the ability of the video-based “Methods video” intervention to decrease incident pregnancy among a cohort of HIV-serodiscordant and HIV-concordant positive couples who had previously participated in CVCT and were offered the full range of contraceptive methods. Among couples who were using a contraceptive method before the intervention, viewing the “Methods video” was associated with a substantially reduced pregnancy incidence during follow-up. In this group, the “Methods video” intervention had its greatest impact among couples with HIV-positive women. The lack of impact in couples who were not using contraceptives before the video-based intervention suggests that repetition and sustained messaging may be needed to increase comfort with all modern contraceptives and with unfamiliar LARC methods in particular.
In our previous publication of the baseline data, a multivariate regression analysis showed that couples who viewed the “Methods video” were were more likely to adopt injectables [risk ratio (RR) = 1.55, 95% CI: 1.03 to 2.34] relative to OCPs, and couples viewing both Methods and Motivational videos were more likely to adopt injectables (RR = 1.65, 95% CI: 1.07 to 2.55) and IUD, Norplant implant or tubal ligation (RR = 2.06, 95% CI: 1.17 to 3.44) relative to OCPs. The “Motivational” video alone did not have a significant impact on contraceptive initiation,32 though it was associated with a substantially higher proportion of couples writing wills and naming guardians.32,37
Although virtually all (99%) participating couples initiated some type of modern contraception after entering the study, the “Methods video” intervention was not associated with lower pregnancy incidence among women using only condoms or no contraception before the intervention, regardless of serostatus. More research is needed to determine the barriers women and couples face when deciding to adopt modern contraception, particularly LARC. In a longitudinal study in Rwanda among 684 cohabiting couples recruited to participate in an HIV testing and counseling program, the greatest increase in condom use occurred in couples where the men were being targeted with a specialized message after having received a generic message 2 years prior.38 Similarly, the Centers for Disease Control and Prevention Curriculum for outreach workers for use in training outreach workers and HIV educators highlights the importance of repetition when delivering HIV prevention messages using the “risk, recognition, response” framework.39
The “Methods video” intervention was most successful among concordant positive couples and couples in which the woman was positive. Post hoc analyses showed that fertility goals differed by gender and by couple HIV status as follows: women were less likely than men to want more children and men in concordant HIV-positive unions were less likely to want more children than men in discordant couples. This reinforces the importance of involving men and women jointly in fertility decisions and highlights the importance of having these discussions in the context of known couple HIV status.
Potential limitations to our study include limited generalizability because those who participated may be different from the target population by having an increased desire/receptivity for CVCT and/or family planning (self-selection bias). We expect the results of this study to make inference to the target population of HIV-concordant HIV-positive and HIV-discordant couples in urban Zambia, a group that will expand given the April 2012 release of WHO Guidelines strongly endorsing CVCT as an HIV prevention strategy. We have previously published that the IC explained all methods and thus increased knowledge of all methods before the intervention.32 The IC also clarified that all methods would be offered to all participants, and this may have attenuated the difference between control and intervention groups. For example, there was high uptake of contraceptive methods—including Norplant—even in the “Control” video arm. This highlights the importance of simply providing basic information about, and access to, the full range of contraceptive options. We acknowledge that provider bias may have also affected contraceptive method choice despite training of project nurses in the provision of all contraceptives and in research methods.
Strengths of this study include its randomized design in which 2 educational interventions were evaluated concurrently, in comparison to most studies of family planning interventions, which are observational or quasi experimental.
In sub-Saharan Africa with high fertility and a high prevalence of HIV/sexually transmitted infection in heterosexual populations, there is a simultaneous need to prevent unplanned pregnancy and HIV transmission. CVCT and family planning service target audiences overlap broadly and can benefit from, and in fact prefer, joint services.40–45 Governments and funding agencies agree that HIV/sexually transmitted infection and family planning services should be integrated.46,47 PMTCT of HIV through prevention of unplanned pregnancies is less expensive than PMTCT with antiretrovirals.48–51
This study evaluated how a family planning intervention offered within the context of CVCT may reinforce HIV and unplanned pregnancy prevention and address client and provider-level obstacles. This successful integration of CVCT and family planning services, a key goal of the US Global Health Initiative and the President’s Emergency Plan for AIDS Relief program, can provide a paradigm for other countries in Africa and beyond.
The authors acknowledge and thank the study participants, staff, interns, and Project Management Group members of the Zambia-Emory HIV Research Project in Lusaka, Zambia. The authors also thank Michelle Kautzman, MD, MPH, Laurie Fuller, RN, MPH, Fong Liu, MD, MPH, Erin Shutes, MPH, Lisa Jones, RN, MPH, and Tyronza Sharkey, MPH, for their contributions to study implementation.
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Keywords:© 2013 Lippincott Williams & Wilkins, Inc.
couples’ voluntary HIV counseling and testing; family planning; long-term contraception; randomized controlled trial; Zambia