Worldwide, hormonal contraceptives are among the most popular reversible methods of family planning. About 18% of married women in higher resource countries report using oral contraceptives (OCs) (UN 2011), as have 17% of women in the USA (Jones 2012). In lower resource areas, the figure for OC use is 7%. The injectable depot medroxyprogesterone acetate (DMPA) is used by an estimated 3.5% of women globally (UN 2011), including 2.3% of women in the USA (Jones 2012). Therefore, more than 145 million women worldwide report using hormonal contraceptives (UN 2011).
Despite high theoretical effectiveness of hormonal methods, typical use has less favorable results. For example, in the USA, the first-year failure rate for typical use of OCs is about 9%, whereas it is only 0.3% for perfect use (Trussell 2011). The wide gap between theoretical and actual effectiveness is attributed to human factors. Several types of hormonal contraceptives depend on adherence to the regimen, which is often called 'compliance' in the medical literature. Repetitive and correct use by the woman is critical for successful use of OCs, progestin-only pills, the transdermal patch, the vaginal ring, and to some extent injectable contraceptives. In contrast, the effectiveness of long-acting hormonal contraceptives, such as the levonorgestrel intrauterine system (LNG IUS) and subdermal delivery systems (i.e., implants), depend less on remembering to use them. In those cases, continuation, rather than adherence to the regimen, determines success.
Hormonal contraceptives in general are characterized by both poor adherence and relatively high discontinuation rates. Reasons include hormonal side effects (Davie 1996; Lei 1996), problems with access (White 2011), or confusion about pill-taking instructions (Westhoff 2007). Nearly half of OC users miss one or more pills each month, and more than a fifth miss two or more (Rosenberg 1998). Difficulties in correct pill-taking may lead to discontinuation and to unintended pregnancy. Analysis of an insurance claims database in the USA indicated more than 35% of new OC users did not refill their prescriptions at three months (Murphy 2008). Also in the USA, prescription refills for hormonal contraceptives were analyzed, and included the vaginal ring, transdermal patch, OCs, and DMPA (Nelson 2008). By three months, only 48% to 61% of women had timely prescription refills, depending on the contraceptive method. A randomized trial showed OC discontinuation of 51% for adolescents provided with seven pills packs and 35% for those given three packs (White 2011). In Brazil, 45% of pill users discontinued in the first 12 months; 12% due to side effects (Leite 2007). Unintended pregnancies related to OC use are estimated to account for 20% of the 3.5 million annual unintended pregnancies in the USA (Rosenberg 1995; Rosenberg 1999). The cumulative discontinuation figures for levonorgestrel subdermal implants range from 10% to 13% at one year to 28% at two years (Fleming 1998; Glasier 2002). A review of multinational data reported 43% discontinuation for the single-rod implant by three years (NCCWCH 2005). For DMPA, multinational data indicate 50% discontinuation for DMPA at one year (NCCWCH 2005). In Brazil, the discontinuation rate for injectables was 64% for the first 12 months, with 27% related to side effects (Leite 2007).
An 'ideal' contraceptive would be characterized by easy use, minimal side effects, excellent tolerability, and high continuation rates. The search for such a contraceptive led to the introduction of low-dose pills and combined injectables, as well as new contraceptive delivery systems, such as the transdermal patch, hormone-releasing intrauterine system, and intravaginal ring. Low-dose contraceptives were developed over a 20-year period and have less estrogen than their predecessors. The estrogen reduction was intended to lower risk of adverse health events while combining estrogen and progestin to maintain efficacy (Gallo 2013). Combined injectable contraceptives contain a progestin plus an estrogen. They were developed to address negative side effects of progestin-only formulations; some have better bleeding patterns than progestin-only injectables (Bartz 2011). However, the new methods have not been associated with substantial improvement in contraceptive continuation or adherence. OCs containing 20 μg of ethinyl estradiol had higher discontinuation rates, which were related to more irregular bleeding (Gallo 2013). For the combined monthly injectable containing medroxyprogesterone acetate (MPA) and estradiol cypionate, continuation in the first year was reportedly 52% (Hall 1997). About 15% of treatment cycles while using the vaginal ring were not consistent with the dosing regimen (Dieben 2002). The women had ring-free time periods that were longer, shorter, or more frequent than recommended. During the first year of use, at least 25% of women discontinued the LNG IUS, often considered close to an 'ideal' contraceptive (Diaz 2000). A review of international data indicated 60% discontinuation at five years for users of an intrauterine device (IUD) or LNG IUS (NCCWCH 2005).
Given that even close to ideal methods are characterized by far from ideal adherence or continuation, contraceptive continuation may depend on factors other than method characteristics and the woman's willingness or ability to follow the regimen. The quality of family planning services may affect contraceptive acceptability and continuation. Within the first year of starting a method, 7% to 27% of women stop using contraception for reasons that could be addressed during family planning counseling, including side effects and health concerns related to the contraceptive method (Blanc 2002). Quality of services is defined by provider skills, quality of information provided, client-provider interactions, and continuity of care (Jain 1989; Blanc 2002; ARHP 2004). An individualized approach to family planning services would focus on individual needs assessment and interpersonal relations between the consumer and the provider (Rudy 2003; ARHP 2004).
An important component of family planning service is providing the client with objective and harmonized information about contraceptive methods. Various counseling interventions are aimed to cover knowledge gaps about correct contraceptive use (Little 1998) and typical side effects (Blanc 2002), to improve the woman's understanding of the method and the consequences of inaccurate use. The available data that counseling improves contraceptive knowledge and use. A Canadian survey indicated that women who had counseling also had more accurate responses on the majority of questions about OC use, benefits, and side effects (Gaudet 2004). Client-provider relations and information provided can affect contraceptive acceptability and continuation (Jain 1989).
The intent was to determine the effectiveness of ancillary counseling techniques to improve adherence to, and continuation of, hormonal methods of contraception.
Criteria for considering studies for this review
Types of studies
Eligible studies were randomized controlled trials of one or more intensive counseling techniques or other client-provider interventions (any type) versus routine family planning counseling approaches for the improvement of adherence and continuation.
Types of participants
Eligible participants were women of reproductive age without medical contraindications to hormonal methods of contraception.
Types of interventions
Eligible interventions were client-provider interventions such as group motivation; structured, peer or multi-component counseling; and intensive reminders of follow-up appointments or next dosing. These were designed to facilitate the use of hormonal methods of contraception and compared to routine methods of family planning counseling.
Types of outcome measures
Outcome measures included the following:
- discontinuation and reasons for discontinuation
- number of missed pills
- number of on-time injections
Search methods for identification of studies
Through August 2013, we searched the following computerized databases for randomized controlled trials (RCTs) comparing client-provider interventions with standard family planning counseling: Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE using PubMed, POPLINE, and EMBASE. We searched for recent trials via ClinicalTrials.gov and the search portal of the International Clinical Trials Registry Platform (ICTRP). Strategies are shown in Appendix 1. Strategies for the 2011 update can be found in Appendix 2. For the initial review (2005) and the 2008 update, the search also included LILACS, PsycINFO, Dissertation Abstracts Online, African Index Medicus, and IMEMR (Appendix 3).
Searching other resources
For the initial review, we examined the reference lists of identified articles and wrote to experts in the field to seek trials we might have missed. We unsuccessfully attempted to locate and contact the authors of two unpublished randomized trials for more information about their studies.
Data collection and analysis
Selection of studies
One author evaluated the titles and abstracts in the literature searches to determine whether they met the inclusion criteria. A second author also examined the reports identified for appropriate categorization.
Data extraction and management
One author extracted the data and entered the information into RevMan. This includes the Characteristics of included studies and the outcome data (Data and analyses; Additional tables). Another author conducted a second data extraction and verified correct data entry. Any discrepancies were resolved by discussion.
Assessment of risk of bias in included studies
We assessed the methodological quality of the trials using recommended methods (Higgins 2011). We focused on the method of randomization; the number of women randomized and excluded or lost to follow up; and the use of allocation concealment and blinding.
Measures of treatment effect
We calculated the Mantel-Haenszel odds ratio (OR) for dichotomous outcomes. For continuous variables, the mean difference (MD) was computed; RevMan uses the inverse variance approach. For all analyses, 95% confidence intervals (CI) were also computed. Any discrepancies were resolved by discussion. Since the studies identified were so different in both exposures and outcomes, we did not conduct a meta-analysis.
Dealing with missing data
We wrote to the investigators of potentially eligible studies to request additional information if needed.
The quality of the evidence was assessed using GRADE principles (Higgins 2011). We summarized the quality of evidence for each study. For the 2013 update, we added a category for randomization and allocation concealment. Grade levels were high, moderate, low, or very low. RCTs were considered high quality and then downgraded for each of the following: a) randomization sequence generation and allocation concealment: no information on either or one was inadequate; b) losses to follow up were 20% or greater; c) all outcomes were self-reported or data were unavailable on objective outcomes; d) intervention focused on reminders without additional health education.
Description of studies
Results of the search
The 2013 search resulted in 63 unduplicated references. From the main databases, we obtained 36 citations. In addition, we identified 24 ongoing clinical trials, and we obtained three articles from other sources such as reference lists.
Nine RCTs met the criteria for inclusion in the review. One was multi-site (Berenson 2012) and eight were single-site (Jay 1984, Keder 1998; Canto De Cetina 2001; Gilliam 2004; Hou 2010; Kirby 2010; Castaño 2012; Trent 2013).
Jay 1984 compared peer counseling with nurse counseling to improve adolescent adherence to OCs. Inclusion and exclusion criteria were not specified. From an adolescent gynecology clinic in Georgia (USA), 57 females wanted to use OCs and agreed to participate in the study. They were randomly assigned to the peer-counselor or nurse-counselor group. All participants were followed up at one, two, and four months. Non-adherence was measured with a four-factor Guttman scale that included 1) became pregnant during the previous month, 2) missed appointment, 3) reported missing three or more OCs during the month, and 4) had absence of urinary fluorescence at the follow up. The latter is a method for monitoring the use of the prescribed OC and riboflavin pill (Silberstein 1966). The four-month loss rate included failing to keep the second rescheduled appointment that had been broken or discontinuing the OC regimen.
Canto De Cetina 2001 compared structured counseling with routine counseling to improve adherence in women receiving DMPA for contraception. The study enrolled 350 women at a family planning clinic in Merida, Yucatan (Mexico), who chose DMPA for contraception. Structured pre-treatment counseling was provided through a uniform set of audiovisual messages on risks, benefits, and overall characteristics of the injectable contraceptive. The information included the mode of action of DMPA and common side effects. The counseling emphasized the potential side effects would not be detrimental to the participant's health. These indications were repeated at each follow-up visit. Women were encouraged to return to the clinic for any DMPA-related concerns. Participants in the control group received routine information on the expected side effects of DMPA. The study assessed side effects, discontinuation at 12 months, and reasons for discontinuation. The cumulative discontinuation at 12 months included those lost to follow up.
Gilliam 2004 provided an antepartum, multi-component intervention that included counseling, a videotape about oral contraceptives (OCs), and written material about OCs. The comparison was resident-physician counseling, which aimed to increase adherence to OCs and decrease repeat unplanned pregnancies in young women. Women in the intervention group received one-on-one counseling by a nurse, watched the videotape, and received six informational sheets, which the nurse reviewed. The study enrolled 43 women during their antepartum visits, but not all used OCs. The study randomized 33 women and assessed adherence to OCs at one year as still using OCs, switched to a different method, not using contraception, and pregnancy. Data were collected at enrollment (between 34 weeks and term); immediately following the intervention; and at 6 weeks, 6 months, and 12 months postpartum.
The intervention in Kirby 2010 used motivational interviewing via phone calls to improve contraceptive use among adolescents. From a reproductive health clinic in San Francisco, CA (USA), 805 young women were enrolled. Over 12 months, up to nine calls could be provided, which were monthly for the first 6 months and then every other month. The comparison group had usual care from the reproductive health clinic, which only made calls to report abnormal results or respond to patients' inquiries. The relevant outcomes were pregnancy (self-report) and correct use of hormonal contraceptives (DMPA, transdermal patch, and OCs).
Berenson 2012 was conducted in five public clinics for reproductive health in southeast Texas (USA). A total of 1155 women were randomized to one of three study arms: 1) Standard care from nurse practitioner with written protocol for new OC users; 2) Counseling included standard care plus 45 minutes of contraceptive counseling from study staff; 3) Counseling plus phone calls by contraceptive counselor, which occurred weekly until initiation and then monthly for 6 months, as well as access to a 24-hour toll-free number. The intervention duration was six months, with telephone follow up at 3, 6 and 12 months. The relevant outcomes were OC adherence (assessed as consistent OC use) and pregnancy, which was obtained from self-report as well as review of all medical records at the end of study.
Four trials provided intensive reminders of appointments or next dosing. The older study used mail and telephone (Keder 1998). The three newer trials sent text messages to cell phones, two of which also provided educational text messages (Castaño 2012; Trent 2013).
In Keder 1998, a system of intensive reminders was compared to the regular written appointment cards to improve adherence to DMPA. The trial enrolled 250 women who selected DMPA for contraception while attending a hospital clinic in Pittsburgh, Pennsylvania (USA). All women were given a written appointment card for their next injection, scheduled for 12 weeks. The reminder group also received mail and telephone reminders. They were sent a letter two weeks before each scheduled injection, and were called if they failed to keep their appointment. The trial evaluated discontinuation at 12 months, degree of satisfaction, side effects, reasons for discontinuation, and number of on-time injections. We combined those lost to follow up and the discontinued participants to analyze discontinuation rates at 12 months. Participants who received their DMPA injections within 14 weeks of the prior injection were classified as 'on-time.'
In Hou 2010, the experimental group received daily text messages to remind them to take their OCs. Controls were not sent reminders. The 82 participants were recruited from a family planning clinic in Boston, MA (USA). They had to have a personal mobile phone with text-messaging capability. Outcomes included the number of missed pills per cycle, which were measured with an electronic monitoring device and diaries. Cycles one through three were assessed; we analyzed the first and third in this review.
Castaño 2012 focused on OC continuation among young women, and was conducted in a family planning health center in Brooklyn, NY (USA). Routine care included contraceptive counseling and a handout. The experimental intervention included routine care plus 180 daily text messages. The messages provided reminders to take OCs daily and addressed six domains of OC knowledge. i.e., risks, benefits, side effects, use, effectiveness, and mechanisms of action. OC continuation, i.e., participant reported taking pill during the last 7 days, was assessed by phone at six months. Also assessed were no missed pills, interruptions in OC use longer than seven days, and use of OC at last sexual intercourse.
The pilot project of Trent 2013 addressed adherence to appointments for DMPA injections among young women. The location was an urban academic practice in Baltimore, MD (USA). Standard of care included counseling and clinic appointment reminders, as well as a call from nurse case manager after missing a scheduled re-injection appointment. The experimental intervention included daily text appointment reminders, starting 72 hours before a scheduled clinical visit; monthly health messages on use of condoms, weight control, DMPA side effect management, and an STD testing reminder; and a call for missed appointment or for no reply to an appointment reminder (or other text message).
Seven trials assessed adherence: on-time injections (Keder 1998; Trent 2013); non-compliance (Jay 1984); switched contraceptives (Gilliam 2004); missed pills (Hou 2010; Castaño 2012); or consistent OC use (Berenson 2012).
In 2013, we excluded two unpublished trials that were included in the original review (Andolsek 1982; Burnhill 1985). We re-examined the reports to synthesize the results, given the greater number of studies in the update. We noted that the outcome measures for Andolsek 1982 were not limited to hormonal methods, but rather grouped hormonal and non-hormonal methods. We had included discontinuation data earlier, but only found one significant difference (in dissatisfaction with method). The intervention in Burnhill 1985 was individualized, and apparently did not focus on hormonal methods. No data had been included from that report due to unclear denominators. Exclusion of these trials did not affect the overall review conclusions.
Six new trials were excluded in 2013 (Gilliam 2010; Langston 2010; Carneiro 2011; Behboodi 2013; Madden 2013; Schwandt 2013). Some interventions and outcome measures were not specific to hormonal methods. Others did not have relevant outcome measures for this review. Details are provided in Characteristics of excluded studies.
Risk of bias in included studies
Trent 2013 was recently completed; a conference abstract provided the only outcome data. Design information came from the listing in ClinicalTrials.gov.
Randomization methods were specified for seven trials that used computer-generated sequences (Jay 1984; Keder 1998; Gilliam 2004; Hou 2010; Kirby 2010; Berenson 2012; Castaño 2012; Trent 2013). Three trials provided the method of allocation concealment (Gilliam 2004; Hou 2010; Castaño 2012; Trent 2013).
Six trials had some blinding. Research team members were blinded to group participation in three studies (Gilliam 2004; Hou 2010; Trent 2013) and outcome assessment was blinded in three (Jay 1984; Kirby 2010; Berenson 2012). Of the remaining three trials, the investigators and research team members were not blinded in two (Keder 1998; Castaño 2012), and one did not report whether any blinding was used (Canto De Cetina 2001).
Incomplete outcome data
Six trials had losses of 20% or more:
- Berenson 2012 lost 44%;
- Jay 1984 reported losses of 42% and 23% in the nurse-counselor and peer-counselor groups, respectively, for 33% overall;
- In Keder 1998, loss to follow up was 36% overall (34% in the reminder group and 38% in the no-reminder group);
- Castaño 2012 lost 28% from the intervention group and 30% of the control group;
- In Kirby 2010, overall loss was 25%;
- Gilliam 2004 lost 24% overall (11% in the intervention group and 40% in the control group).
Other potential sources of bias
Four trials did not have objective outcome measures (Canto De Cetina 2001; Gilliam 2004; Kirby 2010; Castaño 2012). Gilliam 2004 obtained pregnancy data on only 9 of the 33 women randomized. The report provided the pregnancies by study group but not the distribution of the nine women by study group.
The five studies that had objective measures used a range of methods. Hou 2010 assessed the number of missed pills per cycle with an electronic monitoring device. Berenson 2012 used medical records for pregnancy rates. Others assessed on-time injections Keder 1998 or on-time appointments for injections (Trent 2013). The use of a biomarker to assess pill use strengthened the results of Jay 1984, given the limitations of self-reported data to measure adherence among OC users (Stuart 2009). However, this objective outcome was reported as part of a scale which included self-reported missed pills. The investigators used regression to adjust for potential confounding. However, the outcomes reported (and used in this review) appeared to be crude rather than adjusted measures, meaning that the estimates were still based on randomized groups.
Effects of interventions
Five trials tested counseling interventions. Three focused on use of oral contraceptives:
- Jay 1984 showed the adherence scores at four months were not significantly different for the peer-counseling and nurse-counseling groups (for using oral contraceptives). The mean difference was near zero ( Analysis 1.1). These appeared to be crude results (unadjusted for other factors), although the report was not clear on this point. The losses at four months were similar for the two groups.
- Gilliam 2004 did not find any significant differences between those in the multi-component intervention and the control group. The groups were not significantly different in the proportions that continued OC use at one year ( Analysis 2.1) or those who switched the type of contraceptive used ( Analysis 2.2). Of nine women with pregnancy data, three were from the intervention group and two were in the control group. The power to detect differences was limited since the sample size was small. Loss to follow up was lower in the intervention group (OR 0.19; 95% CI 0.03 to 1.13).
- In Berenson 2012, participants were assigned to special counseling about OCs plus follow-up phone calls (C+P), special clinic counseling about OC use, or usual clinic services. At 3 months, but not 12 months, the group with special counseling plus phone calls (C+P) was more likely than the special counseling group to report consistent OC use (OR 1.41; 95% CI 1.06 to 1.87) ( Analysis 3.1). The group with counseling but no phone calls did not differ significantly from the group with standard care for any outcome. In addition, the study groups did not differ significantly for pregnancy ( Analysis 3.3).
Of the other two trials, one focused on DMPA use and one included use of DMPA, the transdermal patch, or OCs:
- Canto De Cetina 2001 showed a statistically significant difference in discontinuation rates between the participants who received structured counseling and those who were given routine information about DMPA. The odds ratio for discontinuation at six months was 0.36 (95% CI 0.20 to 0.64) ( Analysis 4.1), and at 12 months the OR was 0.27 (95% CI 0.16 to 0.44) ( Analysis 4.2). Women in the structured-counseling group were less likely to discontinue the method due to menstrual disturbances (amenorrhea and irregular and heavy bleeding) than women in the routine-counseling group (OR 0.20; 95% CI 0.11 to 0.37) ( Analysis 4.3). The two groups were not significantly different for discontinuation rates due to other medical problems (pregnancy, weight gain, vomiting, dizziness, depression, and loss of libido). Loss to follow up was low and similar for the two groups as well.
- For Kirby 2010, the researchers provided additional data on request. However, the original analysis involved multiple linear and logistic regression repeated measures, and included adjustments for differences between groups. The study groups were reportedly not significantly different for correct use of contraceptives (DMPA, skin patch, and OCs) ( Table 1). Self-reported pregnancy was reportedly similar for the two groups at the end of the study. The investigators provided the reported pregnancy rates by group: 27% treatment and 23% control.
Two trials addressed use of OCs:
- In Hou 2010, one group received daily text-message reminders to take their OCs. They were not significantly different from the controls for the mean number of missed pills per cycle at cycle one ( Analysis 5.1) or cycle three ( Analysis 5.2). These results are from the electronic monitoring device. The groups were also similar for missed pills according to the diaries. However, the mean number of missed pills ranged from 1.1 to 1.4 from the diaries and 3.5 to 5.8 from the electronic monitoring device.
- For Castaño 2012, the text-message group received daily reminders to take OCs. The messages included education about OCs benefits and instructions to avoid medication errors. Women in the text-message group were more likely than the standard-care group to still be using OCs at six months (OR 1.54; 95% CI 1.14 to 2.10) ( Analysis 6.1). The investigators also assessed OC use interruption longer than seven days. The text-message group was more likely to have avoided such an interruption (OR 1.53; 95% CI 1.13 to 2.07) ( Analysis 6.2).
Two studies addressed DMPA use:
- In Keder 1998, intensive reminders were compared to the regular written appointment cards. The investigators found no significant difference in DMPA discontinuation at one year between the reminder and control groups ( Analysis 7.1). There were also no substantial differences between the two groups in on-time injections for those who continued DMPA or for the participants overall ( Analysis 7.2; Analysis 7.3). Loss to follow up was similar for the two groups.
- Trent 2013 provided daily text reminders for appointments, starting three days before scheduled appointment, plus monthly health messages. The conference abstract for this pilot study provided insufficient data for analysis here. Reportedly, 87% completed all three injection appointments, but fewer than half had complete adherence to schedule. Further, the abstract reported no significant difference between the groups in timeliness for the second and third injections.
Summary of main results
The trials on this topic provided limited evidence on whether different counseling or reminder strategies improved adherence to, or continuation of, hormonal contraceptives. Three trials showed some effect of the special intervention. They indicated improved DMPA continuation overall (Canto De Cetina 2001), more OC continuation (Castaño 2012), and more consistent OC use in the short-term (Berenson 2012). The DMPA study also indicated the intervention group was less likely to discontinue due to menstrual disturbances. This suggests some benefit of counseling about contraceptive side effects, which often dominate women's decisions about family planning methods. Enhanced counseling and reminders may have some effect on contraceptive continuation, and may change the reasons why women stop using contraception.
Overall completeness and applicability of evidence
The type and intensity of the experimental interventions varied across the studies. Three trials had multiple counseling contacts for each group (Jay 1984; Kirby 2010; Berenson 2012) as opposed to multiple components during one visit (Gilliam 2004). Four studies focused on reminders rather than counseling (Keder 1998; Hou 2010), of which two provided health information as well as reminders (Castaño 2012; Trent 2013). The studies that showed some difference provided multiple counseling contacts for the special intervention group (Canto De Cetina 2001; Berenson 2012) or multiple reminders and health information (Castaño 2012). The nature as well as the intensity of the intervention may be associated with successful use of contraception.
The studies primarily addressed OCs and DMPA; one also included the transdermal patch. None examined counseling for users of the vaginal ring, an implant, an IUD, or the LNG IUS. The ring requires user action similar to that for the patch. Counseling about correct use and providing reminders could reduce errors and discontinuation rates. For long-acting methods such as implants and intrauterine systems, women could benefit from appropriate counseling about side effects and the importance of continuation.
Eight studies were conducted in the USA, and most were in urban clinics or family planning centers. One took place in Mexico. Six focused on adolescents or young women up to 25 years old. The external validity may be a limiting factor for this review. The individual study findings may be specific to the setting. While all were initiated within clinics, many provided outreach during the follow-up period by telephone or text message. The content and process of counseling or reminder interventions may be appropriate for a local population or clinic and not relevant universally, so effects may differ across groups and sites.
Quality of the evidence
We assessed the quality of evidence using GRADE principles (Higgins 2011). The level was based primarily on study design; downgrading was based on information regarding randomization sequence generation and allocation concealment, losses to follow up, outcomes being self-reported, or the intervention provided reminders only. We summarized the trial results and quality assessment ( Table 2). The overall quality of evidence for this review was considered moderate. While one pilot study had high-quality evidence, the information from the abstract was limited. The evidence was moderate quality for four trials and low for the remaining four.
Ascertainment bias may have arisen in two ways. First, assessment of subjective outcomes may have been influenced by the lack of treatment blinding. If present, however, it did not produce favorable results. In addition, self-reported data has limited value for measuring continuation and consistency of contraceptive use due to social desirability bias (Stuart 2009). Six studies also used some objective measure, i.e., pregnancy, urinary riboflavin in an adherence scale, on-time injections or appointments, and an electronic monitoring device.
This review has limitations that warrant cautious interpretation of the results. Six studies had high losses to follow up. After randomization, losses to follow up that exceed 20% can jeopardize trial validity (Strauss 2005). Three trials and one pilot study had small sample sizes (Jay 1984; Gilliam 2004; Hou 2010; Trent 2013), which increased the likelihood of a Type II error.
Most trials included in this review randomized participants within the center. This method can lead to some 'contamination' across study groups, due to participants sharing information. Such sharing would reduce the likelihood of finding a difference between the groups.
Implications for practice
Good personal communication between clients and providers is generally considered important for successful use of hormonal contraception. Some evidence from randomized controlled trials indicates that use of oral contraceptives and injectables can be improved with enhanced counseling or intensive reminders plus health information. Therefore, a combination of intensive counseling and multiple contacts and reminders may help improve adherence to, and acceptability of, these contraceptive methods.
Implications for research
The published trials provided moderate quality evidence for our purposes. Several had small sample sizes and most had high losses to follow up. Four trials did not have objective outcome measures; self-reports have unknown validity. No eligible trial examined use of the vaginal ring, an implant, or an intrauterine system. High-quality RCTs with adequate power and well-designed interventions could help identify ways to improve adherence to, and continuation of, hormonal contraceptive methods. A trial with randomization at the clinic level or a non-randomized multi-site comparative study may provide additional information.
Carol Manion of FHI 360 assisted with literature searches.
Data and analyses
- Top of page
- Authors' conclusions
- Data and analyses
- What's new
- Contributions of authors
- Declarations of interest
- Sources of support
- Index terms
Appendix 1. Search strategies, 2013
MEDLINE via PubMed (01 Sep 2010 to 04 Sep 2013)
(counseling[title/abstract word] OR reminders[title/abstract word] OR "peer counseling"[title/abstract word]) AND (compliance[title/abstract word] OR adherence[title/abstract word] OR discontinuation[title/abstract word] OR continuation[title/abstract word] OR acceptability[title/abstract word]) AND ((depot medroxyprogesterone acetate[title/abstract word] OR contraceptives, oral[MeSH]) OR (contracep* AND implant*) OR norplant[title/abstract word] OR jadelle[title/abstract word] OR implanon[title/abstract word] OR "sino implant"[title/abstract word] OR sino-implant[title/abstract word] OR "subdermal implant"[title/abstract word] OR (contracept* AND injectable*) OR (vagina* AND ring) OR (contraceptive agents and ring) or (contraceptive devices and (ring or patch)) OR "transdermal contraceptive patch"[title/abstract word] OR "NET-EN"[title/abstract word] OR "Mesigyna"[title/abstract word] OR Cyclofem[title/abstract word] OR "intrauterine system"[title/abstract word] OR IUD[title/abstract word] OR IUS[title/abstract word]) AND Clinical Trial[ptyp]
CENTRAL (2010 to 08 Jul 2013)
Title, Abstract, Keywords: contracept*
AND Title, Abstract, Keywords: counsel* OR educat* OR intervention*
AND Title, Abstract, Keywords: compliance OR acceptability OR continu* OR discontinu* OR adhere*
POPLINE (2010 to 08 Jul 2013)
(counsel* OR reminder*) AND (compliance OR adherence OR acceptability OR discontinuation OR continuation) AND ((oral AND contracept*) OR Depot medroxyprogesterone acetate OR NORPLANT OR implant* OR (injectable AND contracept*) OR (vagina* AND ring) OR NET-EN OR Mesigyna OR Cyclofem OR (intrauterine OR IUD OR IUS) OR (contracept* AND patch))
EMBASE (01 Apr 2008 to 08 Jul 2013)
'counseling'/exp OR reminder AND ('compliance'/exp OR acceptability OR acceptors OR acceptance OR discontinuation OR continuation OR adherence) AND ('norplant'/exp OR implant* OR injectable* OR inject* OR ('oral'/exp AND contracept*) OR 'medroxyprogesterone'/exp OR (vagina* OR contracep AND ring) OR (contracept* AND patch) OR 'iud'/exp OR ius OR 'intrauterine'/exp) AND ([controlled clinical trial]/lim OR [randomized controlled trial]/lim)
ClinicalTrials.gov (01 Oct 2010 to 08 Jul 2013)
Search terms: (counseling OR reminders) AND (compliance OR acceptability OR continuation OR discontinuation OR adherence)
Study type: Interventional studies
Condition: NOT (HIV OR diabetes OR glaucoma)
ICTRP (01 Oct 2010 to 08 Jul 2013)
Intervention: counsel* OR reminder* OR educat* OR intervention
Recruitment status: All
Appendix 2. Search strategies, 2011
MEDLINE via PubMed (through 06 Jan 2011)
We used the recommended Cochrane search strategy revised for PubMed searches (Robinson 2002):
((randomized controlled trial [pt] OR controlled clinical trial [pt] OR randomized controlled trials [mh] OR random allocation [mh] OR double-blind method [mh] OR single-blind method [mh] OR clinical trial [pt] OR clinical trials [mh] OR ("clinical trial" [tw]) OR ((singl* [tw] OR doubl* [tw] OR trebl* [tw] OR tripl* [tw]) AND (mask* [tw] OR blind* [tw])) OR ("latin square" [tw]) OR placebos [mh] OR placebo* [tw] OR random* [tw] OR research design [mh:noexp] OR comparative study [mh] OR evaluation studies [mh] OR follow-up studies [mh] OR prospective studies [mh] OR control* [tw] OR prospective* [tw] OR volunteer* [tw]) NOT (animal [mh] NOT human [mh])) AND (counseling[title/abstract word] OR "intensive reminders"[title/abstract word] OR reminders[title/abstract word] OR "peer counseling"[title/abstract word] OR "structured counseling"[title/abstract word] OR counseling[title/abstract word]) AND (compliance[title/abstract word] OR adherence[title/abstract word] OR discontinuation[title/abstract word] OR continuation[title/abstract word] OR acceptability[title/abstract word]) AND ((depot medroxyprogesterone acetate[title/abstract word] OR contraceptives, oral[MeSH]) OR NORPLANT[title/abstract word] OR implants[title/abstract word] OR "contraceptives, injectable"[title/abstract word] OR "vaginal ring"[title/abstract word] OR "NET-EN"[title/abstract word] OR "Mesigyna"[title/abstract word] OR Cyclofem[title/abstract word] OR "levonorgestrel-releasing intrauterine system"[title/abstract word] OR "transdermal contraceptive patch"[title/abstract word])
CENTRAL (through 14 Oct 2010)
contracept* in Title, Abstract or Keywords AND (counsel* OR educat* OR intervention*) in Title, Abstract or Keywords AND (compliance OR acceptability OR continu* OR discontinu* OR adhere*) in Title, Abstract or Keywords
POPLINE (through 01 Nov 2010)
counseling & (compliance/ adherence/ acceptability/ discontinuation/ continuation) & (oral contraceptives/ Depot medroxyprogesterone acetate/ NORPLANT/ implants/ injectable contraceptives/ vaginal ring/ NET-EN/ Mesigyna/ Cyclofem/ levonorgestrel-releasing intrauterine system/ transdermal contraceptive patch) & (compar*/ clinical trials/ comparative studies/ random/ double-blind studies)
ClinicalTrials.gov (01 Jan 2006 to 29 Oct 2010)
Search terms: (counsel* OR educat* OR intervention*) AND (compliance OR acceptability OR continu* OR discontinu* OR adhere*) NOT (non-randomized OR endometrial OR endometrioma OR mifepristone OR misoprostol)
Condition: NOT (HIV OR diabetes OR glaucoma)
Intervention: contraceptive OR contraception
Study type: interventional studies
Gender: studies with female participants
ICTRP (01 Jan 2006 to 29 Oct 2010)
Condition: contraceptive OR contraception
Intervention: counsel OR counseling OR counselling OR educate OR education OR intervention
Appendix 3. Search strategies, 2005 and 2008
Strategies included MEDLINE, CENTRAL, and POPLINE (Appendix 2) as well as those shown below.
EMBASE, PsycINFO and Dissertation Abstracts Online
counseling AND (compliance OR user(w)compliance OR acceptability OR acceptors OR acceptance OR discontinuation OR continuation OR adherence) AND(Norplant OR ((implant OR implants OR injectable OR injectables OR drug implant OR drug injection) AND hormonal contraception) OR oral contraceptive agent OR medroxyprogesterone(w)acetate OR vaginal(w)ring OR contraceptive(w)patch OR (levonorgestrel AND (IUD OR IUS OR intrauterine device OR intrauterine(w)system)
Counseling OR intensive reminders OR "peer counseling" OR "structured counseling" [Words] and Compliance OR discontinuation OR continuation OR acceptability OR patient acceptance of health care [Words]
African Index Medicus
(Counseling or counselling or reminders) NOT (AIDS or HIV)
counseling or reminders
Last assessed as up-to-date: 4 September 2013.
Protocol first published: Issue 3, 2003
Review first published: Issue 1, 2006
Contributions of authors
V Halpern developed the idea, did the primary data extraction for the initial review and drafted the review. For the initial review, LM Lopez did the secondary data extraction and wrote part of the review. For the updates (2008 to 2013), LM Lopez reviewed the search results, extracted data, and revised the review. DA Grimes participated in writing the initial review, and did the secondary data extraction for two updates (2008 and 2010). In 2013, LL Stockton extracted data and checked data entry. MF Gallo provided assistance with data extraction for the initial review.
Declarations of interest
DA Grimes has consulted with the pharmaceutical companies Bayer Healthcare Pharmaceuticals and Merck & Co, Inc.
Sources of support
- No sources of support supplied
- U.S. Agency for International Development, USA.
- National Institute of Child Health and Human Development, USA.
Medical Subject Headings (MeSH)
Contraception [*psychology]; Contraceptive Agents, Female [*administration & dosage; adverse effects]; Contraceptives, Oral, Hormonal [administration & dosage; adverse effects]; Counseling; Medication Adherence [*psychology]; Medroxyprogesterone Acetate [administration & dosage; adverse effects]; Randomized Controlled Trials as Topic; Treatment Refusal [*psychology]
MeSH check words
* Indicates the major publication for the study