JAIDS Journal of Acquired Immune Deficiency Syndromes:
Impact of Long-Term Contraceptive Promotion on Incident Pregnancy: A Randomized Controlled Trial Among HIV-Positive Couples in Lusaka, Zambia
Wall, Kristin M. MS, PhD*,†; Vwalika, Bellington MD, MMED, MSc*; Haddad, Lisa MD, MS, MPH*,‡; Khu, Naw H. MPH*,§; Vwalika, Cheswa MD, MPH*; Kilembe, William MD, MSc*; Chomba, Elwyn MD, DCH*; Stephenson, Rob PhD*,‖; Kleinbaum, David PhD*,†; Nizam, Azhar MS*,¶; Brill, Ilene MPH*,#; Tichacek, Amanda MPH*,§; Allen, Susan MD, MPH*,§
*Rwanda Zambia HIV Research Group, Department of Pathology and Laboratory Medicine, School of Medicine and Hubert Department of Global Health, Rollins School of Public Health and Laney Graduate School, Emory University, Atlanta, GA
†Department of Epidemiology, Rollins School of Public Health and Laney Graduate School, Emory University, Atlanta, GA
‡Department of Gynecology and Obstetrics, Emory University School of Medicine, Atlanta, GA
§Department of Pathology and Laboratory Medicine, School of Medicine, Emory University, Atlanta, GA
‖Department of Global Health, Rollins School of Public Health and Laney Graduate School, Emory University, Atlanta, GA
¶Department of Biostatistics and Bioinformatics, Rollins School of Public Health and Laney Graduate School, Emory University, Atlanta, GA
#Department of Epidemiology, University of Alabama at Birmingham, Birmingham, AL.
Correspondence to: Kristin M. Wall, MS, PhD, Department of Epidemiology, School of Public Health, Emory University, 1518 Clifton Road NE, 3rd Floor, Atlanta, GA 30322 (e-mail: firstname.lastname@example.org).
Supported by the National Institutes of Child Health and Development (NICHD RO1 HD40125); National Institute of Mental Health (NIMH R01 66,767); the AIDS International Training and Research Program Fogarty International Center (D43 TW001042); the Emory Center for AIDS Research (P30 AI050409); National Institute of Allergy and Infectious Diseases (NIAID R01 AI51231); and the International AIDS Vaccine Initiative.
Presented at meeting as “Wall KM, Bellington V, Haddad L, Htee Khu N, Vwalika C, Kilembe W, Chomba E, Stephenson R, Kleinbaum D, Nizam A, Brill I, Tichacek A, Allen S. Effect of an intervention to promote contraceptive uptake on incident pregnancy: a randomized controlled trial among HIV positive couples in Zambia” at AIDS Vaccine 2012; September 2012, Boston, MA. Abstract submission number 247684.
The authors have no conflicts of interest, including relevant financial interests, activities, relationships, and affiliations.
Trial registration number: NCT00067522 (registered at clinicaltrials.gov).
Received September 14, 2012
Accepted November 19, 2012
Objectives: To evaluate the impact of family planning promotion on incident pregnancy in a combined effort to address Prongs 1 and 2 of prevention of mother-to-child transmission of HIV.
Design: We conducted a factorial randomized controlled trial of 2 video-based interventions.
Methods: “Methods” and “Motivational” messages promoted long-term contraceptive use among 1060 couples with HIV in Lusaka, Zambia.
Results: Among couples not using contraception before randomization (n = 782), the video interventions had no impact on incident pregnancy. Among baseline contraceptive users, viewing the “Methods video” which focused on the intrauterine device and contraceptive implant was associated with a significantly lower pregnancy incidence [hazard ratio (HR) = 0.38; 95% confidence interval (CI): 0.19 to 0.75] relative to those viewing control and/or motivational videos. The effect was strongest in concordant positive couples (HR = 0.22; 95% CI: 0.08 to 0.58) and couples with HIV-positive women (HR = 0.23; 95% CI: 0.09 to 0.55).
Conclusions: The “Methods video” intervention was previously shown to increase uptake of long-acting contraception and to prompt a shift from daily oral contraceptives to quarterly injectables and long-acting methods such as the intrauterine device and implant. Follow-up confirms sustained intervention impact on pregnancy incidence among baseline contraceptive users, in particular couples with HIV-positive women. Further work is needed to identify effective interventions to promote long-acting contraception among couples who have not yet adopted modern methods.
Total fertility rates (TFR) in Africa are among the world’s highest, and though knowledge of modern contraception is increasing, women in many countries do not have access to these methods.1–3 The United Nations has emphasized family planning as critical for economic recovery and development in Africa, and African countries are adopting family planning to advance maternal and child health, improve human rights, and moderate demographic trends. Some successes have been observed as follows: the TFR in Rwanda decreased from 8.5 pre-genocide4 to 5.0 in 2010.5 Until 2010, Zambia’s fertility was declining, with a TFR of 7.2 in 1980, 6.7 in 1990, and 6.0 in 2000.6 A TFR of 5.2, the lowest observed in Zambia, was recorded from 2003 to 2009. However, the TFR has increased in recent years to 6.1 in 2010 and 6.0 in 2011.7
Barriers to family planning in sub-Saharan Africa include: reduced contraception availability; lack of knowledge about available contraception methods [especially long-acting reversible methods such as the copper intrauterine device (IUD) and the contraceptive implant]; fear of side-effects (especially among HIV-positive women); and social, cultural, and religious practices discouraging contraception use and encouraging childbearing.8–11 Additionally, many women are not decision makers within the family, and African men often control sexual and familial economic decision making.12–14
Long-acting reversible user-independent contraceptive (LARC) methods, including the IUD and the contraceptive implant, are not subject to user error or resupply like oral contraceptive pills (OCPs) and injectables, making them more effective at preventing pregnancy and more cost-efficient over the long term.15 Barriers to IUD and implant use include client misconceptions about safety, lack of understanding about their mechanism of action, and lack of culturally sensitive marketing to increase knowledge and allay concerns related to LARC methods.16,17 Few nurses in sub-Saharan Africa have the training to provide these contraception methods to patients.18 This leads to poor knowledge of LARC methods among patients because nurses are not inclined to discuss what they are not comfortable or able to provide.19 This cycle can be overcome by addressing supply-and-demand aspects concurrently by giving providers didactic training to improve knowledge and practical skills to ensure their comfort with insertions and removals, in tandem with medical education for clients.20,21
In Zambia, policies adopted in 1989 emphasized the goal of reducing population growth by controlling fertility22 through increasing family planning services, raising the age of marriage, improving the status of women, providing family planning education, and incorporating economic incentives for reduced fertility.23 The Zambian government endorses the complete range of contraceptive options with an emphasis on “method mix” and the capacity to provide all methods.24 Today, user-dependent methods like daily OCPs and progesterone-based injectables like depot medroxyprogesterone acetate, which must be administered every 13 weeks, are the most common methods used in Zambia.25 Overall, contraceptive use is 23% among women of reproductive age, and 17% use a modern form of contraception.26 Less than 2% of women use a LARC method.
Despite social marketing efforts for family planning in Zambia and efforts by the Planned Parenthood Association of Zambia to include men in family planning services,27 spousal communication is often poor.28 Findings from a community-based contraceptive distribution program suggest that involving both partners enhances service delivery and that involving men directly is more productive than asking women to discuss and negotiate family planning issues with their spouses.29–31
In areas of high HIV prevalence and total fertility, it is critical to find family planning interventions that are effective and feasible in reducing unintended pregnancies. We present the results of a randomized controlled trial evaluating whether a video-based family planning intervention with a particular focus on LARC methods [addressing prong 2 of preventing maternal-to-child transmission (PMTCT)] influenced time to pregnancy among HIV-serodiscordant and HIV-concordant positive couples obtaining couples’ voluntary HIV counseling and testing (CVCT) services (addressing prong 1 of PMTCT) in Lusaka, Zambia.
The study design and contraceptive uptake after 2 video interventions have been previously reported,32 as has the impact of the informed consent (IC) on knowledge of contraceptive methods and beliefs about efficacy and side effects.33 Briefly, a factorial randomized controlled trial was designed to evaluate 2 interventions to promote contraceptive use among HIV serodiscordant and concordant positive couples identified from CVCT clinics in Lusaka, Zambia. Consecutively numbered envelopes were prepared in the United States and shipped to Zambia, each containing a random assignment to “Methods,” “Motivation,” “Methods + Motivation,” or “Control” videos in a 1:1:1:1 ratio. Couples viewed the designated videos followed by a counselor-facilitated discussion. The “Methods” video presented information about contraceptive methods starting with the LARC methods, specifically IUD and implant, followed by depot medroxyprogesterone acetate, OCP, emergency contraception, and permanent methods (tubal ligation and vasectomy). The “Motivational” video modeled future planning behaviors in a dramatized format; the impact of this intervention on will writing, financial planning, and appointing guardians has been previously published.33 A “Control” video contained information on hand washing, bed net use, and nutrition. Enrollment began in July 2002 and follow-up ended May 2006, before widespread availability of antiretrovirals in Lusaka. The study was approved by Office for Human Research Protections–registered Institutional Review Boards at Emory University and in Zambia. Written IC was obtained from all participating couples.
Outcome of Interest
The outcome of interest was time to pregnancy, operationalized as clinically confirmed pregnancy or a positive pregnancy test at a follow-up visit (follow-up visits were scheduled every 3 months, with the possibility of client-initiated interim visits as needed). Participants were censored at death, loss to follow-up/dropout, exit interview, or the defined end date of the study.
Exposures of Interest
The exposure of interest was the arm of trial. Covariates of interest included sociodemographics, sexual behavior and health descriptors, and women’s contraceptive history. Sociodemographic and health and contraceptive history variables, including household income, English language ability, occupation, religion, and fertility intentions, were collected at baseline before the intervention.34 Time-varying variables, including contraceptive method uptake during follow-up, seroconversion during follow-up, and method stopping/starting/switching, were collected at 3-month interval visits or at interim visits. The HIV stage variable was derived from laboratory staging (based on hematocrit and sedimentation rate) and clinical staging (based on variables from physical exam and past medical history).35,36
Couple Eligibility and Recruitment
Participants were recruited from couples referred after CVCT at the Zambia Emory HIV Research Project in Lusaka, Zambia.36 Eligible participants were HIV-serodiscordant or HIV-concordant positive couples cohabiting >12 months who had no indications of infertility or contraindications to contraception, were not pregnant at enrollment, and planned to stay in Lusaka at least 1 year post enrollment. Eligible women were 18–45 years of age, and eligible men were 18–65 years of age.
Couples with no children and couples in which the man wanted more children in the next year were not considered to be at risk for avoiding pregnancy and were excluded from this analysis.32 Analyses also excluded couples without at least 1 follow-up visit. Among randomized couples, the proportion analyzed was similar in the Methods (70%) and No Methods (71%) arms (Fig. 1).
Counts and percentages of categorical participant demographics and means and standard deviations of continuous variables were calculated by intervention arm. The χ2 (or Fisher exact) tests for categorical variables and t tests for continuous variables evaluated significant differences between client demographics and intervention arm to explore potential failures of randomization due to chance. These differences were compared across study arms and stratified by baseline contraceptive use, which was determined to be an effect modifier.
Predictors of contraceptive initiation or switching methods immediately after the intervention have been previously reported.32 Potential effect modification by couple serostatus and contraceptive use at baseline (before the intervention) were evaluated in Cox proportional hazards models of time to pregnancy. Baseline covariates that were associated with trial arm, that were risk factors for the outcome, and which were not intermediates on the exposure–outcome pathway were evaluated as potential confounders. The proportional hazards assumption for intervention arm was evaluated for all Cox models via graphical methods and statistical tests. Log-rank tests evaluated significant differences in Kaplan–Meier survival curves by trial arm.
We also conducted a post hoc analysis evaluating the differences in the distribution of man and woman fertility intentions by couple serostatus via χ2 tests. Data analysis was conducted with SAS 9.3 (Cary, NC).
After exclusions for ineligibility (n = 2975), 1502 couples were randomized to 1 of the 4 intervention arms. One hundred forty-five couples were excluded from the analysis for having no follow-up visits, 137 couples were excluded due to the man’s desire for more children in the next year, and 160 couples were excluded for having no living children. The final analysis included 1060 couples (Fig. 1).
We looked for failures of randomization that might arise by chance by trial arm (“Methods video” versus “No Methods video” arms) stratified by woman’s use of a baseline contraceptive method, which was an effect measure modifier. Women who were not using a method at baseline in the “Methods video” arm were less likely to understand English relative to the “No Methods video” arm (Table 1). Also among women not using a method at baseline, women in the “Methods video” arms were less likely to have knowledge about the IUD. Among women who were using a method at baseline, those in the “Methods video” arms were more likely to have knowledge of tubal ligation (Table 2). These variables were evaluated as potential confounders in multivariate models stratified by baseline method use.
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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couples’ voluntary HIV counseling and testing; family planning; long-term contraception; randomized controlled trial; Zambia
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