women have among the highest rates of new hiv infections globally and the rate of new infections has not lessened in recent years [ 14 ] . african americans account for 66% of new hiv infections among all us women over 5 times their proportion representation ( 12% ) in the population . one in 30 african - american women can expect to acquire hiv infection during their lifetime ; the vast majority of these are through heterosexual intercourse . crack - using african - american women are a distinct , hard - to - reach population for whom empowerment to reduce hiv / sti risk takes on additional complexities due to the entangled dependencies of drugs , partnerships with men ( who are often drug involved ) for material support for women and their children , and constant threat of violent reprisal [ 4 , 79 ] . concurrent infection with sti is considered to be endemic among african - american , drug - using , hiv+ women . women 's biological inequality in vulnerability to sexually transmitted infection ( sti ) can be addressed with greater availability and use of male and female condoms ( fc ) . in addition to challenges in the diffusion of available protection technologies , however , gender inequity in sexual relationships , limited bargaining power of women complicated by threats of violence , and insufficient resource commitment to health issues among minorities and the poor all contribute to women 's continuing entrenchment of hiv / aids in the united states . the fc is the only female - initiated protection method that protects against hiv / sti and unwanted pregnancy at a level equivalent to a male condom ( mc ; ) . full integration of the fc has lagged far behind in hiv prevention efforts [ 1214 ] . interventions for us populations at high risk   infrequently ( 4 of 14 studies ) included information and counseling on the fc , although most studies were targeted to heterosexual risk groups . formal cdc documents on voluntary counseling and testing ( vct ) do not specifically refer to fc as integral to the counseling approach . effective interventions targeted to drug - using women to reduce sexual risk are few in number and , as pointed out by wechsberg et al . , have rarely involved follow - up intervals of longer than 6 months . studies with short - term followup evaluating effective intervention approaches have included two woman - focused interventions : the co - op model   as well as the nida standard model tested by sterk and colleagues , as against two enhanced models . the womens ' co - op intervention is a brief 4-session intervention with mixed individual and group sessions , based on empowerment and feminist theory , encouraging women to understand their hiv risks in the context of substance abuse and effects on personal power and vulnerability to victimization . numerous adaptations have been conducted since the first trial of the intervention , which resulted in its recognition as a best evidence intervention , based on results from 6-month followup . long - term followup ( 4 years ) of 60% of the original study population , however , found evidence of differential attrition favoring the retention of the high - risk participants and lack of long - term sustained salutary effects observed at 6 months . sterk and colleagues   followed 333 mainly crack - using women who were randomly assigned to three different conditions . with 96% retention at 6 months , positive change was demonstrated in drug use behavior and sexual risk behavior , as well as drug - related sexual risk behavior such as sex trade . however , no differences among the nida standard and woman - focused interventions were found . the enhanced interventions were based on five behavioral theories with a gender- and culture - specific focus . all conditions involved access to prevention methods and included practice of negotiation and protection techniques and technologies . the behavioral intervention tested here (  bestbet  ) integrated elements from three existing theories  the theory of gender and power , community empowerment theory , and risk reduction / harm reduction theory  as well as an original theory of  body empowerment . the latter draws heavily from feminist health principles espoused widely in the 1970s in such works as our bodies , ourselves . the bestbet intervention was initially developed as a multiple session , clinic - based intervention among hiv+ women , and has evolved through a series of studies on diverse populations of high - risk women [ 2325 ] . increased body knowledge appeared to facilitate use of women 's barrier methods in these studies because risk behavior declined . we believed that active crack / polydrug users would attend a relatively long , multisession intervention with women - focused content despite the inherent physical and mental challenges involved . we posited that the woman - specific intervention themes would have cross - cutting relevance and produce positive behavioral change among this population at very high sexual risk for hiv / sti .   in this paper , we describe a randomized controlled trial of an intervention (  bestbet  ) from a sample of 198 drug - using women with high - risk sexual behavior who were followed for 12 months . the feminist health model as applied to hiv underscores the need for holistic education about reproductive organs and genitals , rather than a narrow focus on hiv . our intervention included session content on normal female anatomy , the menstrual cycle , pregnancy , menopause , sti signs and symptoms , female cancers , benefits of screening ( mammography and pap smear ) , and common surgeries . the body empowerment approach posits that increased knowledge , sense of ownership , and pride in the body (  body knowledge  ) are an independent pathway to self - esteem and to self - efficacy for protection behavior  use of female - initiated barriers , mc negotiation with partners , and refusal of unsafe sex . thus , we introduced to intervention women the entire range of female methods thought possibly to reduce risk of sti / hiv  female condom , diaphragm , cervical cap , and spermicides ( the study was initiated prior to the findings concerning vaginal irritation with nonoxynol-9 ; we counseled women to abandon use of spermicides for disease protection following publication of the findings)arranged  hierarchically  according to what was known about protection level   in a harm reduction approach to increasing protection behavior ( i.e. ,  something is better than nothing  ) . we also focused on the need for female solidarity and mutual support . these four pillars body knowledge , access to female initiated methods , emphasis on harm reduction , and a setting promoting female solidarity  provided the intervention core components . we integrated content on female and male barriers in each intervention session , focusing on practical applications of the fc with diverse partners , including paid sexual transactions ( e.g. ,  cheeking  or oral application of mc without partner initiation ) concomitant with drug use ( e.g. , inserting an fc before getting high ) , and situations of potentially violent partners ( inserting cervical barrier with spermicide for discreet risk reduction ) . women tried the female barriers at home and shared their experiences at the following group session , where troubleshooting for problems encountered in the initial adoption period was facilitated by a trained counselor . the impact of basic body education coupled with access to a full range of female barrier options on decreasing sexual risk behavior has not , to our knowledge , been evaluated in active substance users . for this trial , we enhanced certain elements and adapted the study to target out - of - treatment drug users . we added a session dedicated to intimate partner violence ( for paying , nonprimary , and primary partners ) including a module on basic self - defense techniques and exit strategies and use of protection methods in the context of forced sex . the intervention was held at a university - operated , community storefront site with a long history of provision of hiv counseling and testing in a poor , inner city neighborhood . the elements of the intervention were ( 1 ) small groups with interactive counseling ; ( 2 ) trained and certified near - peer community counselors with a history of substance abuse and in recovery for at least 2 years ; ( 3 ) role play and rehearsal , ( 4 ) multimedia educational approaches , such as videos , audio tapes , brochures , posters , and anatomical models ; ( 5 ) active referrals to local service organizations ; ( 6 ) access to hiv testing ; and ( 7 ) training of cbo staff for community capacity building . audio tapes of diverse risk vignettes based on interviews with the target population and accompanying illustrated handouts were prepared by an outside nonprofit health organization . we collaborated with a nearby branch of a national family planning organization to facilitate diaphragm and cervical cap fittings and offered patient advocate support to accompany study participants to clinic appointments . to be eligible for the bestbet study , we required women to ( 1 ) be 18 years of age or older , ( 2 ) be hiv seronegative , ( 3 ) report 30% or more unprotected vaginal or anal sex acts over the preceding three months ( averaged over all partners ) , ( 4 ) report not currently being in drug user treatment other than with methadone , and ( 5 ) report that heroin or cocaine were either injected , snorted , or smoked at least 12 times during the same three - month interval . women were excluded for psychiatric problems or if they had been in drug treatment for more than 6 months . because changing drug use behavior was not an explicit study objective , we did not exclude women from attending sessions if they were  high  except if such use disrupted group dynamics . eligible women were recruited in philadelphia between november 2001 and august 2003 , with the use of a mobile outreach van staffed with trained interviewers and harm reduction counselors . the van was parked in designated , high - risk areas known for crack - selling and smoking activity . interested women gave the first written consent to be administered a 20-minute , confidential prescreening assessment interview that included demographic and behavioral risk items as well as to provide locator information . the second screening assessment was conducted at a community storefront site that served as an information and referral center for drug users . recruitment and study methods have , in part , been presented in a prior publication . this study was approved by and conducted in compliance with the institutional review board of the university of pennsylvania . participants completed a baseline risk assessment instrument delivered via audio , computer - assisted self - interview ( a - casi ) targeting sexual and drug user behavior over prior 6 months . additional baseline data were collected in a face - to - face interview including the following : demographic and reproductive health history , history of sti , health care insurance , and types and location of health care services used in past 6 months . following baseline data collection , all women received enhanced hiv and sti harm - reduction counseling that exceeds standard guidelines for hiv voluntary counseling and testing ( vct ) ; both the mc and fc were taught . we counseled women with sti on treatment locations and required these women to bring written confirmation of treatment for formal enrollment . we provided hiv - positive women with referrals for further counseling and care but they were excluded from this study . women randomized to the intervention arm were invited back for five , 3-hour , weekly group sessions within 2 months of enrollment and were contacted for 6- and 12-month reunion sessions at community sites . control participants received limited case management and the offer of free mcs and fcs , but no other proactive study intervention . at 6- and 12-month following enrollment , all assessments were repeated at the community sites or other locations when necessary . masters ' level interviewers were trained and certified in vct and in standardized interviewing techniques . intensive retention efforts ( phone , mailed correspondence , and in person ) were used to follow participants considering their mobility , including community outreach , visits to known crack houses and other hang - outs , and hospital and prison outreach . retention challenges were discussed weekly in study meetings . using multiple methods and extensive efforts to locate hard - to - reach participants , the retention rate was 95% at 12 months . to test for differences between the control and intervention groups at baseline , chi - square for dichotomous variables and independent sample t - test for continuous variables were conducted for demographic variables and background characteristics . univariate analyses including frequencies and percentages were completed to describe the total sample and its subsets at baseline and 12-month follow - up . our main outcome variable , frequency of unprotected vaginal intercourse ( monthly ) , is the focus of this paper . data for this analysis were derived from a series of questions delivered via a - casi , asking first , the total frequency of acts during the interval ( vaginal , anal , and oral ) followed by the frequency of acts protected by mc or fc , diaphragm , cervical cap , or spermicide ( these latter three related only to vaginal sex ) . the remainder was defined as unprotected vaginal sex acts . protected and unprotected vaginal sexual acts were calculated at baseline and at 12-month followup for two types of partners : primary partners and hiv - negative nonprimary partners . the number of hiv - positive nonprimary partners was prohibitively small to include for analysis . a primary ( male ) partner was described as  someone you have lived with or have seen a lot , and to whom you have felt a special emotional commitment . if a woman answered that she did not have vaginal sex in the prior interval ( this was only possible at followup ) or did not have that type of partner , she was considered as having zero frequency of unprotected acts . for this study we used an intent - to - treat analysis with the inclusion of women who may not have been sexually active during followup and/or may not have had a primary or nonprimary sexual partner . pairwise analysis was performed on the outcome variable separately for primary and nonprimary partners from baseline to followup , for each intervention arm , which included generating a paired sampled t - test ( p < 0.05 was considered significant ) . for comparison of intervention versus control arms , first a  change either parametric ( student 's t - test ) or nonparametric tests ( mann - whitney u test ) were used to assess statistical significance , depending on the normality of distribution . all analyses were conducted using spss version 19.0 ( spss , inc . , chicago , illinois ) . a total of 1134 women were prescreened at the van . of the 616 eligible women , 304 ( 49% ) successfully completed the baseline interviews and specimen collection and were invited to participate in the bestbet study . among eligible women completing baseline interviews ( n = 304 ) , of these women , 227 ( 75% ) returned for enrollment procedures and were randomized ( 113 as intervention subjects and 114 as controls ) . twenty - nine women were later excluded based on contradictory information related to eligibility criteria ( see figure 1 ) . a slightly greater percentage of eligible women who completed baseline interviews , as compared to the final study group , reported drug injection ( 49% versus 42% ) and somewhat fewer had health insurance ( 65% versus 70% ) . the majority of the study participants were african - american ( see table 1 ) . a majority of participants were unemployed with nearly two - thirds reporting use of food stamps . most women had a history of drug treatment , with crack / rock cocaine and marijuana as the drugs of choice . most participants ( c 79.8% , i 85.9% ) had a primary male sex partner , and more than half ( c 56.6% , i 60.6% ) had both a recent nonprimary male sex partner(s ) and a primary partner . women with primary partners reported substantial levels of recent ( past 6 months ) intimate partner violence : 21% had partners who had made threats on their life , 34% had been forced to have vaginal or anal sex without a condom , 25% had been punched or hit with something that hurt , and 11% had consulted medical care because of a fight ( data not shown ) . no significant differences across arms were found . at baseline , the overall mean frequency of unprotected vaginal sex acts ( all enrolled women ) with primary partners in the past 6 months was 34.3 ( median = 12 ) , and with nonprimary , hiv - negative partners was 22.7 acts ( median 0 ) . at 12-month followup , the overall mean frequency of unprotected vaginal sex acts ( all enrolled women ) with primary partners was 15 . 6 ( median 0 ) ; with nonprimary hiv - negative partners the follow - up mean frequency was 2.9 acts ( median 0 ) . a total of 189 women completed assessments at 12-month followup ( retention rate : 95.4% ) . for the paired baseline - to - followup comparisons , among controls , for primary partner , baseline frequency was 32.7 acts ; at 12 months this was reduced to 19.3 acts ( paired t - test , p = 0.008 ; see table 2 ) . among intervention women , mean of unprotected vaginal acts at baseline for primary partner was 35.9 and at follow - up was 12.3 ( paired t - test , p = 0.000 ) . for control women with nonprimary hiv partners , mean baseline frequency of unprotected vaginal acts was 21.6 acts ; at 12-month followup frequency was 2.5 ( paired t - test , p = 0.000 ) . among intervention women , frequency of unprotected vaginal acts with non- primary hiv - partners at baseline was 23.8 , and at 12-month followup was 3.5 ( paired t - test , p = 0.002 ) . a statistical test of the change over time ( i.e. , reduction in unprotected acts ) , per partner type , compared across arms , indicated borderline significance for primary partners ( p = 0.075 ) , favoring the intervention arm . for nonprimary partners , no statistical difference could be detected between the change observed across the two arms from baseline to followup ( p = 0.80 ) . proportions of women reporting mc use were greater in both arms in cross - sectional analyses comparing baseline to followup . mc use with primary partners was lower than with nonprimary partners across both arms , at both baseline and followup ( table 3 ) . intervention women reported mc use with primary partners more frequently at followup but the difference across arms was not statistically significant for either primary or nonprimary partners . mc use with nonprimary partner was reported by two - thirds ( i ) and three - quarters ( c ) of women ; the higher rates in i women at follow - up were achieved despite lower usage at baseline with nonprimary partners ( i versus c ) . use of the fc was also substantially higher at followup than at baseline in both arms . the lowest proportions of women reporting fc use at followup were c women with nonprimary partners ( 7% ) . use of spermicide and cervical barriers was also greater at followup compared with baseline for all women except c women with their nonprimary partners . very few protected acts involved spermicide use alone and only 1 woman reported use of a cervical barrier unaccompanied by either mc or fc use . thus , followup method use as compared with baseline method use appeared to increase the least when considering the subgroup  control women - nonprimary partners . for i women , by contrast , there were consistent and substantial differences when comparing baseline to followup , with both partner types and across all methods . the sample of active , drug - using women in this study demonstrated large changes in risk behavior over 12-month follow - up . frequency of unprotected sex acts dropped significantly for both study arms , across both partner types . the difference in frequency of unprotected sex for both study arms was modified by partner type . for primary partners , statistical significance would likely have been realized with greater numbers due to the large variability in the outcome measure . for nonprimary partners , there was no observed difference across the study arms ; women in both arms reported substantial increases in protection . our findings agree with those of others indicating that use of mc is less frequent with a primary partner than with nonprimary partners ; nevertheless , the results with primary partner for intervention women are encouraging as these partners are often considered to pose a greater risk of sti / hiv transmission to drug - using women . although both types of counseling reduced unprotected acts , the  value - added  impact of the group - based intervention appeared to reside mainly with primary partners . in our study , fc use also increased in both arms , with greater and more uniform increases among i women . in particular , at followup , fewer c women used fc with nonprimary partners , with proportions that were significantly different from i women . we have previously shown that introduction to the fc and other female protection methods promoted mc negotiation and possibly a greater rejection of unprotected sex . these findings taken together suggest that our group - based intervention treatment was superior in encouraging behavior change . prior studies among drug - using women have often suffered from short follow - up periods . study participants who used fc found the method sufficiently practical to use with primary and nonprimary partners . there has been a tendency to discount female barrier methods as impractical and unacceptable though no wide - scale evidence supports this contention and indeed there is evidence to the contrary [ 13 , 14 ] . women have potentially more control over fc ( versus mc ) use but its impact will only be realized with strong promotional programs and quality counseling including outreach activities to men wherever possible   and easy access to continuing supplies , to ensure adoption and maintenance of the behavior . the fc should be a regular component of vct , formalized into easily accessible counseling guidelines and promoted widely . a separate analysis of knowledge changes with this intervention   suggests that a key component of fc adoption is empowerment of women through better knowledge of their bodies . such education should be incorporated routinely into future interventions and programs for drug - using women  including , importantly , woman - focused drug treatment programs , still few in number and often lacking a reproductive health approach . our body empowerment approach and counselor training supplied women with key elements to boost the use of female - initiated methods , including cervical barriers and devices that are important and relevant to drug - using women   but poorly promoted and underresearched as a dual protection method . study participants were selected on the basis of specific criteria drawn up to concentrate a high level of drug - related and sexual risk . they agreed and were expected to attend five , relatively long , intervention sessions and return for follow - up assessments . other drug - using populations with a lower risk profile or less availability for study procedures might have demonstrated different results . nevertheless , we used a - casi , an established technique to increase the validity of reporting of sensitive behavior in numerous populations . additionally , there was high variability in frequency of reported unprotected acts at both time points . these considerations tend to mitigate concerns about reporting bias , though there is no way of eliminating this possibility . comparisons of fc and mc use proportions were cross - sectional due to high levels of changes in partner and sexual activity . drug - using women continue to be at extremely high risk for hiv / sti , with large demonstrated racial disparities , despite successful inroads made for other at - risk populations in the interim , such as non - injection - using men who have sex with men ; additional approaches are still urgently needed . arm , as we designed two alternative counseling approaches that could be used in the field ; thus changes over time can not be attributed to the intervention procedures with complete confidence and may be due in part to the additional time duration spent with counselors . of concern , we may well have underestimated the impact of our intervention as compared to mc counseling only , which is practiced widely . also , our analysis was based on an intention - to - treat approach ; women assigned to the intervention arm did not necessarily complete all five sessions . the sample size may have been too small to detect some changes that were statistically significant  for example , the differences within main partner across intervention and control arms . finally , contamination of the message across study arms was certainly possible , given the relatively small geographic recruitment area and overlapping social networks ; this too would have acted to minimize observed differences across the study arms . the hiv primary prevention landscape is changing , with oral preexposure prophylaxis ( prep ) as well as postexposure prophylaxis ( pep ) now documented to be valuable tools in the prevention mix and potentially applicable to drug - using populations . the potential for reducing sexual risk with vaginal prep for women is still unclear , with conflicting and recently disappointing results regarding the efficacy of vaginal tenofovir [ 37 , 38 ] . a daily , voluntary application of an antiviral vaginal compound may suffer from poor adherence ; long - term intact options may be considerably more effective . as additional topical microbicidal compounds complete testing , including microbicidally impregnated vaginal devices , the counseling on the use of such methods , especially among women at high risk such as idu and nidu women , will become more routine . our results suggest that active drug - using women at high risk of sexually transmitted hiv / sti will partake of such counseling and capitalize on expanded access to these technologies .
background . we tested an original , woman - focused intervention , based on body empowerment , and female - initiated barrier methods , including the female condom ( fc ) and cervical barriers . 
 methods . 
 eligible women were > = 18 years of age , hiv seronegative , and active drug users , reporting 30% or greater unprotected sex acts . both controls ( c ) and intervention ( i ) 
 participants received enhanced hiv / sti harm reduction counseling . 
 i participants underwent 5 additional weekly group sessions . 
 we compared change in frequency of unprotected vaginal intercourse across arms at 12 months . results . among 198 enrolled women , over 95% 
 completed followup . 
 two - thirds were african - american ; most of them used crack , had a primary partner , and reported sex exchange . in paired t - tests from baseline to followup , the frequency of unprotected vaginal sex dropped significantly for i ( primary p < 0.00 , nonprimary p < 0.002 ) and c ( primary p < 0.008 , nonprimary p < 0.000 ) arms with all partners . 
 the difference in change across arms was of borderline significance for primary partner ( p = 0.075 ) ; no difference was seen for nonprimary partner ( p = 0.8 ) . 
 use of male condom and fc increased with both partner types over time , but more consistently among i women . conclusion : the  value - added  impact of the intervention was observed mainly with primary partners . 
 body knowledge with routine fc counseling should be incorporated into interventions for drug - using women .