Factors Affecting Continued Use of Subcutaneous Depot Medroxyprogesterone Acetate (DMPA-SC): A Secondary Analysis of a 1-Year Randomized Trial in Malawi.
ABSTRACT: OBJECTIVE:To assess the supply- and demand-side factors influencing continued use of the injectable contraceptive subcutaneous depot medroxyprogesterone acetate (DMPA-SC). METHODS:We conducted a 12-month randomized controlled trial in Malawi to measure DMPA-SC continuation rates. A total of 731 women presenting to clinic-based providers (CBPs) at 6 Ministry of Health clinics or to community health workers (CHWs) in rural communities were randomized to receive DMPA-SC administered by a provider or be trained to self-inject DMPA-SC. Data collectors contacted women after the reinjection window at 3, 6, and 9 months to collect data on discontinuation and women's experiences. Twelve months after enrollment or at early discontinuation, women had their final interview, including pregnancy testing. We compared continuation, pregnancy, and safety by whether DMPA-SC or self-injection training was provided by CHWs versus CBPs. We also conducted an exploratory analysis assessing the association between women's sociodemographic factors and the risk for discontinuation using stratified Cox proportional hazards models. FINDINGS:The type of provider did not seem to influence continuation, pregnancy, or safety. As reported previously, women in the self-injection group were significantly less likely to discontinue the method compared with women in the provider-administered group (hazard ratio, 0.43; P<.001). The risk for discontinuation was also different among health facility catchment sites (P<.001). No other assessed sociodemographic factors were found to significantly influence the risk for discontinuation. CONCLUSIONS:Public-sector CHWs can safely and effectively provide DMPA-SC and train women to self-inject DMPA-SC in low-resource settings. DMPA-SC continuation did not seem to be influenced by the type of provider, whether CBP or CHW, or women's sociodemographic characteristics.
Project description:OBJECTIVES:The primary objective of this study was to compare the 12-month continuation rate for women who self-injected subcutaneous depot-medroxyprogesterone acetate (DMPA-SC) with that for women receiving intramuscular depot-medroxyprogesterone acetate (DMPA-IM) from a provider. This research contributes to the broader goal of identifying solutions to support women to use contraception for their full desired duration. STUDY DESIGN:Participants were clients from 13 clinics in the Dakar and Thiés regions of Senegal who had decided to use injectable contraception prior to enrollment. They chose self-injection of DMPA-SC or provider administration of DMPA-IM. Self-injectors were trained and given three units of DMPA-SC. The provider-injected group received DMPA-IM and returned to the clinics for future injections. We interviewed participants at baseline and after the second, third and fourth injections (the equivalent of 12?months of contraceptive coverage). We employed Kaplan-Meier methods to estimate continuation probabilities, with a log-rank test to compare differences between groups. A multivariate Cox regression identified factors correlated with discontinuation. RESULTS:The 12-month continuation rate for 650 women self-injecting DMPA-SC was 80.2%, while that for 649 women receiving DMPA-IM from a provider was 70.4% (p<.01). The difference in continuation between self-injectors and those receiving DMPA from a provider remained significant in a multivariate Cox regression model. The primary reason for discontinuation in both groups (44.7% self-injected; 44.5% provider-injected) was forgetting to reinject or reinjecting late. Fewer women reported side effects in the self-injection group than in the provider-administered group. CONCLUSIONS:The higher 12-month continuation rate for women self-injecting DMPA-SC relative to provider-administered DMPA-IM suggests that self-injection may help prevent pregnancy more consistently and continuously. IMPLICATIONS:Discontinuation of injectable contraception among women wishing to avoid pregnancy may increase unmet need in francophone West Africa. This study showed higher 12-month continuation rates for women who self-injected DMPA-SC, suggesting that this delivery method may improve injectable continuation.
Project description:OBJECTIVES:In 2015, private healthcare providers in Nigeria introduced DMPA-SC (depot medroxyprogesterone acetate administered subcutaneously) into the method mix. We aimed to  examine the sociodemographic predictors of continued DMPA-SC use after 3 months, and  characterize the additional influences of contraceptive counseling quality and experiences of side effects on continuation. STUDY DESIGN:From March to August, 2016, we conducted phone interviews with a convenience sample of women obtaining DMPA-SC from selected providers to survey them about their experience obtaining an initial dose of DMPA-SC. Study coordinators contacted women again about 3 months later after when they were due for reinjection. We used logistic regressions to examine the likelihood of having obtained a subsequent dose of DMPA-SC at follow-up as predicted by sociodemographic characteristics, a quality of counseling indicator based on responses to a 14-item scale, and reports of side effects experienced. RESULTS:Of the 541 DMPA-SC users who completed the first survey, 311 were reached again via phone after 3 months to conduct a second survey. Multivariate results for sociodemographic predictors of continued DMPA-SC use show that those with some college education or more (OR=2.79; 95% CI: 1.09-7.14), and those with four or more children (OR=2.89; 95% CI: 1.09 0 7.67) were more likely to obtain another dose. Our summary quality measure showed that women overall rated the quality of their initial counseling session high. Logistic regressions indicated that higher quality during the initial counseling session is related to the likelihood of getting another dose of DMPA-SC (OR=2.04; 95% CI: 1.12-3.47) whereas experiencing more bleeding reduced the likelihood of continuation after 3 months (OR=0.15; 95% CI: 0.07-0.34). CONCLUSIONS:Among urban Nigerian women, both counseling quality and experiencing side effects were important factors in predicting continued use of DMPA-SC after 3 months. These findings are consistent with previous studies of DMPA and injectable contraception continuation. IMPLICATIONS:New contraceptive methods that are designed for increased access and ease of use, combined with high quality provision, have potential to increase contraceptive use in settings with low levels of contraceptive prevalence. Higher quality counseling can help encourage women's continuation of a new injectable contraceptive method at 3 months.
Project description:To evaluate feasibility, acceptability, continuation, and trough serum levels following self-administration of subcutaneous (sc) depot medroxyprogesterone acetate (DMPA).Women presenting to a family planning clinic to initiate, restart or continue DMPA were offered study entry. Participants were randomized in a 2:1 ratio to self- or clinician administered sc DMPA 104 mg. Those randomized to self-administration were taught to self-inject and were supervised in performing the initial injection; they received printed instructions and a supply of contraceptive injections for home use. Participants randomized to clinician administration received usual care. Continued DMPA use was assessed by self-report and trough medroxyprogesterone acetate levels at 6 and 12 months.Two hundred fifty women were invited to participate, and 137 (55%) enrolled. Of these, 91 were allocated to self-administration, and 90/91 were able to correctly self-administer sc DMPA. Eighty-seven percent completed follow-up. DMPA use at 1 year was 71% for the self-administration group and 63% for the clinic group (p=0.47). Uninterrupted DMPA use was 47% and 48% for the self and clinic administration groups at 1 year (p=0.70), respectively. Serum analyses confirmed similar mean DMPA levels in both groups and therapeutic trough levels in all participants.Sixty-three percent of women approached were interested in trying self-administration of DMPA, even in the context of a randomized trial, and nearly all eligible for enrollment were successful at doing so. Self-administration and clinic administration resulted in similar continuation rates and similar DMPA serum levels. Self-administration of sc DMPA is feasible and may be an attractive alternative for many women.Self-administration of sc DMPA is a feasible and attractive option for many women. Benefits include increased control over contraceptive measures and less time spent on contracepting behaviors. Globally, self-administration has the potential to revolutionize contraceptive uptake by increasing the number of women with access to DMPA.
Project description:OBJECTIVE:To better understand how to educate patients and providers about study findings relevant to treatment guidelines, we assessed pre- versus post-Women's Health Initiative (WHI) differences in menopausal hormone therapy (MHT) initiation and continuation and their correlates, and in women's reasons for initiation and discontinuation. METHODS:We analyzed survey data from up to 14 approximately annual visits over 17 years (1996-2013) from 3,018 participants in the Study of Women's Health Across the Nation, a prospective cohort study. We used logistic regression to compare pre- versus post-WHI associations of covariates with MHT initiation and continuation, and to compare pre- versus post-WHI reasons for initiation and continuation. RESULTS:MHT initiation dropped from 8.6% pre-WHI to 2.8% post-WHI (P?<?0.0001), and the corresponding decrease in MHT continuation was 84.0% to 62.0% (P?<?0.0001). Decreases in MHT initiation and continuation occurred across a range of participant subgroups, consistent with wide dissemination of post-WHI recommendations. However, contrary to current guidelines, we found large declines in MHT use in subgroups for whom MHT is often recommended, that is, younger women and those with more vasomotor symptoms. Post-WHI, women's reasons for MHT initiation and discontinuation reflected concerns highlighted by WHI results. The largest declines in initiation reasons were for reducing risks of osteoporosis and heart disease, whereas the largest increases in discontinuation reasons were for media reports and provider advice. CONCLUSIONS:Immediate post-WHI recommendations for MHT use were widely adopted. MHT risks documented in older women, however, may have led younger symptomatic women to forgo MHT for symptom relief.
Project description:OBJECTIVE:To evaluate the 12-month total direct costs (medical and nonmedical) of delivering subcutaneous depot medroxyprogesterone acetate (DMPA-SC) under three strategies - facility-based administration, community-based administration and self-injection - compared to the costs of delivering intramuscular DMPA (DMPA-IM) via facility- and community-based administration. STUDY DESIGN:We conducted four cross-sectional microcosting studies in three countries from December 2015 to January 2017. We estimated direct medical costs (i.e., costs to health systems) using primary data collected from 95 health facilities on the resources used for injectable contraceptive service delivery. For self-injection, we included both costs of the actual research intervention and adjusted programmatic costs reflecting a lower-cost training aid. Direct nonmedical costs (i.e., client travel and time costs) came from client interviews conducted during injectable continuation studies. All costs were estimated for one couple year of protection. One-way sensitivity analyses identified the largest cost drivers. RESULTS:Total costs were lowest for community-based distribution of DMPA-SC (US$7.69) and DMPA-IM ($7.71) in Uganda. Total costs for self-injection before adjustment of the training aid were $9.73 (Uganda) and $10.28 (Senegal). After adjustment, costs decreased to $7.83 (Uganda) and $8.38 (Senegal) and were lower than the costs of facility-based administration of DMPA-IM ($10.12 Uganda, $9.46 Senegal). Costs were highest for facility-based administration of DMPA-SC ($12.14) and DMPA-IM ($11.60) in Burkina Faso. Across all studies, direct nonmedical costs were lowest for self-injecting women. CONCLUSIONS:Community-based distribution and self-injection may be promising channels for reducing injectable contraception delivery costs. We observed no major differences in costs when administering DMPA-SC and DMPA-IM under the same strategy. IMPLICATIONS:Designing interventions to bring contraceptive service delivery closer to women may reduce barriers to contraceptive access. Community-based distribution of injectable contraception reduces direct costs of service delivery. Compared to facility-based health worker administration, self-injection brings economic benefits for women and health systems, especially with a lower-cost client training aid.
Project description:OBJECTIVE:To describe the implementation and results of a proactive patient outreach project to offer self-administered, depot medroxyprogesterone (DMPA) subcutaneous (SC) to interested patients at a California safety-net clinic following expanded state Medicaid coverage. STUDY DESIGN:We contacted non-pregnant patients at an urban, safety-net hospital-based primary care clinic who had been prescribed DMPA intramuscular (IM) in the past year to gauge interest in self-administered DMPA-SC. Interested patients received a prescription for DMPA-SC and a telehealth appointment with a clinic provider to learn self-injection. We recorded patient interest in DMPA-SC, completed appointments, and completed first injections. We conducted initial outreach in May, 2020 and recorded appointment attendance and completed injections through August, 2020. RESULTS:Of 90 eligible patients (age 17-54), we successfully contacted and discussed DMPA-SC with 70 (78%). Twenty-six (37%) patients expressed interest in DMPA-SC and scheduled telehealth appointments to learn to self-administer the medication. Fifteen (58%) of those interested (21% of the total) successfully self-injected DMPA-SC. Of the 44 (63%) patients not interested in DMPA-SC, the three most common reasons were fear of self-injection (n=23 [52%]), wanting to stop DMPA (n=11 [25%]), and satisfaction with DMPA-IM (n=6 [14%]). CONCLUSION:There is interest in and successful initiation of self-administered DMPA-SC among patients at an urban safety net hospital-based primary care clinic who have used DMPA-IM in the last year.
Project description:The Republic of Benin faces high maternal, newborn, and child mortality; low modern contraceptive use; and a critical shortage of health workers. In 2013, the Government of Benin made 3 reproductive health commitments to improve national health indicators, including expanding provision of family planning services at the community level through task sharing. Since 2016, the Advancing Partners & Communities (APC) project has been helping the Benin Ministry of Health (MOH) provide subcutaneous depot medroxyprogesterone acetate (DMPA-SC; brand name Sayana Press) through facility-based health care providers and community health workers known as relais communautaires (RCs). DMPA-SC is an easy-to-administer, discreet injectable contraceptive that provides 3 months of protection from pregnancy. Beginning in May 2017, the government introduced DMPA-SC through a phased approach in 10 health zones, which encompassed 149 health centers and 614 villages. Between June 2017 and June 2018, the MOH and APC trained 278 facility-based providers and 917 RCs to provide DMPA-SC, and nearly 11,000 doses were subsequently administered to 7,997 women at facilities and in communities. This article presents findings from an assessment of community-level and health facility service data collected during the first 13 months of DMPA-SC introduction in Benin. Because of this intervention, nearly 35,000 women received family planning counseling and 7,997 women chose DMPA-SC. At the community level, 3,111 DMPA-SC users were first-time users of modern contraception. The initial success of the DMPA-SC rollout in Benin shows promise for helping the country meet its reproductive health commitments.
Project description:Background: In vitro, animal, biological and observational clinical studies suggest that some hormonal methods, particularly depot medroxyprogesterone acetate - DMPA, may increase women's risk of HIV acquisition. DMPA is the most common contraceptive used in many countries worst affected by the HIV epidemic. To provide robust evidence for contraceptive decision-making among women, clinicians and planners, we are conducting the Evidence for Contraceptive Options and HIV Outcomes (ECHO) study in four countries with high HIV incidence and DMPA use: Kenya, South Africa, Swaziland, and Zambia (Clinical Trials.gov identifier NCT02550067). Study design: We randomized HIV negative, sexually active women 16-35 years old requesting effective contraception and agreeing to participate to either DMPA, the copper T 380A intrauterine device or levonorgestrel implant. Participants attend a contraception support visit after 1 month and quarterly visits thereafter for up to 18 months. Participants receive a standard HIV prevention package and contraceptive side-effect management at each visit. The primary outcome is HIV seroconversion. Secondary outcomes include pregnancy, serious adverse events and method discontinuation. The sample size of 7800 women provides 80% power to detect a 50% relative increase in HIV risk between any of the three method pairs, assuming 250 incident infections per comparison. Ethical considerations: Several WHO consultations have concluded that current evidence on HIV risk associated with DMPA is inconclusive and that a randomized trial is needed to guide policy, counselling and choice. Previous studies suggest that women without a specific contraceptive preference are willing to accept randomization to different contraceptive methods. Stringent performance standards are monitored by an independent data and safety monitoring board approximately every 6 months. The study has been conducted with extensive stakeholder engagement. Conclusions: The ECHO study is designed to provide robust evidence on the relative risks (HIV acquisition) and benefits (pregnancy prevention) between three effective contraceptive methods.
Project description:INTRODUCTION:Contraceptives improve women's lives and public health, but many women discontinue their contraceptive method owing to dissatisfaction. An underexamined aspect of contraceptive discontinuation is sexual acceptability, or how contraception affects sexual experiences. Investigators' aims were two-fold: 1) to document changes in multiple domains of women's sexual experiences with their intrauterine device (IUD) or contraceptive implant over time and 2) to examine whether these sexuality factors were associated with method continuation at 12 months. METHODS:We enrolled 200 eligible family planning clients and collected data at baseline and at 1, 3, 6, and 12 months. Sexual acceptability measures included the Female Sexual Function Index-6, the New Sexual Satisfaction Scale, and participants' perceptions of whether their contraceptive method had had a neutral, positive, or negative effect on their sex life. Survival analysis and Cox regression with time-varying covariates related sexuality measures to method continuation over time while controlling for other relevant factors. RESULTS:Among 193 women who received an IUD or implant, 20% selected the copper IUD, 46% the levonorgestrel IUD, and 34% the etonogestrel implant. Ten percent discontinued their method during the year. Although changes in Female Sexual Function Index-6 and New Sexual Satisfaction Scale scores were not associated with discontinuation, individuals who perceived that their method detracted from their sexual experience had significantly higher removal rates than those who reported no sexual changes or positive sexual changes (adjusted hazard ratio, 8.04; 95% CI, 1.53-42.24), even when controlling for method type, bleeding changes, and a variety of covariates and controls. CONCLUSIONS:Although limited by the small sample of discontinuers, we found that women's perceptions of how their method affects their sex life were associated with contraceptive continuation over time. Sexual acceptability should receive more attention in both contraceptive research and counseling.
Project description:Access to safe and effective contraceptive choices is a reproductive right and contributes tremendously to improvements in maternal and child health. Progestin-only injectables, particularly intramuscularly injected depot medroxyprogesterone acetate (DMPA-IM), have received increased attention given findings suggesting a potential association with increased HIV risk. For women at high risk of HIV, the World Health Organization's Medical eligibility criteria for contraceptive use currently aggregate recommendations for all progestin-only injectables, including DMPA-IM, subcutaneously injected DMPA (DMPA-SC) and intramuscularly injected norethindrone/ norethisterone enanthate (NET-EN), except in the case of some drug interactions. We considered whether published data indicate differences or similarities between these injectables relevant to risk of acquiring HIV. In vitro data confirm different biological activities of these distinct progestins, including that MPA, and not NET, binds and activates the glucocorticoid receptor resulting in different biological effects relevant to immune function. Limited clinical data suggest changes in immunologic activity following DMPA-IM and NET-EN initiation, but interstudy variation and study design differences diminish ability to determine clinical relevance and the degree to which DMPA-IM and NET-EN could act differentially. The highest-quality epidemiologic studies suggest a potential 40% increase in HIV incidence in users of DMPA-IM relative to women not using hormonal contraception but no significant increase in risk in users of NET-EN. In our opinion, most of the available biologic activity and epidemiologic data indicate that DMPA and NET-EN are likely to act differently, and data remain too limited to evaluate differences between DMPA-IM and DMPA-SC.